[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-heart-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-heart-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,102,0,25,[9,45,72,97,131,163,188,216,246,275,308,334,367,392,419,445,470,499,524,549,581,608,632,658,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100652276","localized-evidence-of-cytokine-adsorption-therapy-during-pediatric-cardiac-surgery-a-single-center-randomized-controlled-trial-leat-100652276",false,"NCT07771491","Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)","LEAT","Inclusion Criteria:\n\n* Children (\\\u003C18 years old at study inclusion)\n* Undergoing a cardiac surgery with CPB of expected duration \\> 180min\n* Prophylactic application of HA during CPB for suspected SIRS.\n\nExclusion Criteria:\n\n* Non-ability to gather informed consent from parents or legal representative. Enrolled in conflicting research study\n* Off-pump procedure\n* Non-steroidal anti-inflammatory treatment in the previous 7 days Pregnancy","ALL","0 Years","17 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients undergoing major heart surgery.\n\nObjective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine.\n\nStudy Population All children \\\u003C 18 years of age at the time of enrollment who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass (CPB) with an expected duration of \\>180 minutes.\n\nMethodology This single-center study will randomly assign patients before surgery into 2 groups: 1 group will receive hemoadsorption treatment plus with standard-of-care (intervention group), while the other group will receive standard-of-care (control group) only.\n\nPrimary Endpoint:\n\nTo evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.\n\nSecondary Endpoints:\n\n1. Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours\n2. PELOD-2 score on ICU admission, at 48 hours post ICU admission\n3. ICU and hospital length of stay\n4. ICU, hospital, and 28 days mortality\n5. Mechanical - ventilation (MV) free days at day\n6. Renal replacement therapy (RRT) free days at day 28\n7. Vasopressors free days at day 28\n8. Acute kidney injury\n9. Bleeding complications\n10. Post operative liver injury\n\nData Collection:\n\nBlood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure .\n\nDuration: The study is expected to last 24 months.",[28,29,30,31,32],"Congenital Heart Disease","Open Heart Surgery","Cardiopulmonary Bypass","Endocarditis Acute and Subacute","Cyanotic Heart Disease","NOT_YET_RECRUITING","2026-08-13",{"date":36,"type":37},"2026-08-18","ACTUAL",{"date":39,"type":22},"2026-10-01",{"date":41,"type":22},"2028-10-31",{"name":43,"class":44},"Norfaniza Zabidi","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":4,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100557746","research-on-body-voice-ai-recognition-system-for-childrens-health-management-100557746","NCT06542120","Research on Body Voice AI Recognition System for Children's Health Management","Intelligent Voice Model: A New Paradigm Exploration for Child Health Management","Inclusion Criteria:\n\n1. Age 0\\~18 years old, gender is not limited\n2. Children who have been diagnosed with congenital heart disease by cardiac ultrasound or who do not have congenital heart disease\n3. Children diagnosed with bronchopneumonia or without bronchopneumonia\n4. Children who are clinically diagnosed with intestinal diseases or who do not suffer from intestinal diseases\n5. Informed consent\n\nExclusion Criteria:\n\n1. ≥ 18 years old\n2. Children who are unable to undergo cardiac ultrasound, chest imaging or other related examinations\n3. Subjects who are unable to obtain informed consent, or who are unwilling to cooperate with the provision of diagnosis and treatment related data for further analysis and research as required by the study.",true,"18 Years",{"count":55,"type":22},30000,"OBSERVATIONAL","The purpose of this research is to develop a body voice artificial intelligence (AI) recognition device, also referred to as an AI-assisted body sound identification device, by utilizing a deep learning-based novel AI algorithm in conjunction with a big body voice model. It could identify normal and abnormal heart, breath, and bowel sounds, and to provide early screening and auxiliary diagnosis of congenital heart disease (CHD), respiratory infections, diarrhea and other common multi-occurring diseases.",[28,59,60],"Bronchopneumonia","Abdominal Disease","RECRUITING","2026-08-11",{"date":64,"type":37},"2026-08-12",{"date":66,"type":37},"2024-05-01",{"date":68,"type":22},"2026-12-31",{"name":70,"class":44},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",5,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100628830","autus-valve-continued-access-study-cas-100628830","NCT07466745","Autus Valve Continued Access Study (CAS)","Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Continued Access Study","Inclusion Criteria:\n\n1. Age 18 months to 16 years.\n2. Male or female.\n3. Subject has a native or repaired right ventricular outflow tract.\n4. Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).\n5. Subject has at least one of the following echocardiographic findings:\n\n   1. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);\n   2. Moderate or greater pulmonary regurgitation;\n   3. Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.\n6. Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).\n7. Subject and parent\u002Flegal representative, where appropriate, are willing to provide informed written consent.\n8. Subject and parent\u002Flegal representative, where appropriate, and treating physician agree that the subject will return for, and comply with, all required study assessments and follow-up visits.\n\nExclusion Criteria:\n\n1. Subject requires valve replacement in a non-pulmonary position.\n2. Subject has a prosthetic valve at other valve position or will need a prosthetic valve at other valve position (i.e., anticipate additional valve replacements needed within 3 years).\n3. Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).\n4. Subject has a known history of pulmonary atresia and major aortopulmonary collaterals.\n5. Subject has significant peripheral pulmonary artery stenosis.\n6. Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).\n7. Subject has active endocarditis or a history of infective endocarditis.\n8. Subject has a known history of renal insufficiency as determined by a serum creatinine (S-Cr) level ≥2.5 mg\u002FdL within 60 days prior to the Screening Visit, or has end-stage renal disease.\n9. Subject has a known history of leukopenia (defined as a white blood cell \\[WBC\\] count \\\u003C3.5 x 103\u002FµL).\n10. Subject has a known history of acute or chronic anemia (defined as hemoglobin \\[Hgb\\] \\\u003C10.0 g\u002Fdl or 6 mmol\u002FL).\n11. Subject has a known history of thrombocytopenia (defined as platelet count \\\u003C50 x 103\u002FµL).\n12. Subject has a known history of hypersensitivity to anticoagulants and antiplatelet drugs.\n13. Subject has a known history of autoimmune disease or receives immunosuppressant and\u002For immunostimulant drugs, and the Investigator or Eligibility Screening Committee (ESC) believes may negatively affect study outcomes.\n14. Subject needs emergency cardiac or vascular surgery or intervention.\n15. Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses.\n16. Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years.\n17. Subject or parent\u002Flegal representative refuses blood transfusions.\n18. Subject has medical, social, or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures.\n19. Subject is participating in an investigational study of a new drug, biologic, or device at the time of study screening.\n\n    \\-","18 Months","16 Years",{"count":82,"type":22},36,[25],"Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implantation, at hospital discharge, 30 days, 6 months, and annually through 10 years.\n\nThe Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject.",[28],"2026-08-06",{"date":88,"type":37},"2026-08-10",{"date":90,"type":37},"2026-07-27",{"date":92,"type":22},"2036-04-30",{"name":94,"class":95},"Edwards Lifesciences","INDUSTRY",10,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":71},"100522242","multicenter-trial-of-ecmo-in-children-with-severe-cardiac-failure-using-the-cardiohelp-system-100522242","NCT06080074","Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System","Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure","TROLLEY","Inclusion Criteria:\n\n1. Age 0 to 16 years of age (i.e., \\\u003C17 years)\n2. Body weight 2.5 to 80 kilograms\n3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.\n4. First ECMO run during the current hospitalization\n5. Written informed consent from the parent or legally appointed representative (LAR)\n\nExclusion Criteria:Children must not meet any of the following exclusion criteria after ECMO cannulation and immediately prior to consent:\n\n1. Gestationally-corrected age \\\u003C37 weeks\n2. Bleeding or coagulopathy that is a contraindication to anticoagulation\n3. Irreversible renal, hepatic or lung failure\n4. Stroke or uncertain neurological status within the past 30 days\n5. Severely malnourished\n6. Use of an ECMO system other than the Cardiohelp\n7. VV-ECMO or ECMO for primary respiratory failure\n8. Goals of patient to focus on comfort measures only.\n9. Failure to separate from cardiopulmonary bypass\n10. Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.\n11. Patients who are pregnant or breastfeeding.\n12. Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)",{"count":106,"type":22},50,[108],"PHASE2","There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to:\n\n1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children.\n2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial\n\nThe main questions the Cardiohelp single-arm trial seeks to answer are:\n\n* What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO?\n* Should the Cardiohelp device be FDA-cleared for children based on the results of the study?\n* What are the optimal performance specifications of the Cardiohelp device in children?\n\nThe main questions the blood thinner randomized trial seeks to answer are:\n\n* Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device?\n* How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner?\n\nChildren who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications.\n\nFor the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured.\n\nThe study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).",[111,112,28,113],"Heart Failure","Cardiogenic Shock","Cardiomyopathies",[115,116,117,118,119,120,121,122],"blood thinner","ECMO","heart failure","bivalirudin","heparin","FDA regulation","pediatric medical devices","510k clearance","2026-08-05",{"date":88,"type":37},{"date":126,"type":37},"2025-04-15",{"date":128,"type":22},"2029-09",{"name":130,"class":44},"Stanford University",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":139,"targetDuration":141,"studyType":56,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100650767","domestication-and-implementation-of-the-pen-plus-clinical-model-in-the-zambian-health-system-100650767","NCT07753681","Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System","PEN-Plus Initiation Grant Opportunity: Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System","PEN Plus","Inclusion Criteria:\n\n* Presenting with chronic NCDs\n\nExclusion Criteria:\n\n* Refusing to be followed up prospectively for routine visits",{"count":140,"type":22},2084,"1 Month","Cognizant of the prevalence of complicated non communicable diseases (NCD) and the attendant capacity problems faced by the health workers in primary care settings, we propose to adapt and pilot the Package of Essential Non-communicable Diseases (PEN) Plus intervention using the Interactive Systems Framework (ISF) and then implement and monitor the impact. The ISF framework proposes and organizes several implementation strategies to achieve Evidence Based Implementation (EBI) adaptation. We will apply these strategies at 2 first level hospitals (Peri-Urban and Rural) to ensure local adaptation and work towards scaling up of the WHO-PEN Plus in the rest of Zambia. This process will be inclusive, involving a Stakeholder Consultation Group that shall include the Zambian Non-Communicable diseases and injuries (NCDI) Poverty Commission and shall report bi-annually to a Project Advisory Board (PAB) chaired by the Permanent Secretary of the Ministry of Health.",[144,145,146,147,111,28,148,149,150,151,152],"Cardiac Diseases","Sickle Cell Disease","Hypertension","Diabetes Mellitus","Rheumatic Heart Disease","Epilepsy","Cancer","Mental Health Disorders","Kidney Disease","2026-08-04",{"date":155,"type":37},"2026-08-07",{"date":157,"type":37},"2022-08-08",{"date":159,"type":22},"2027-09-30",{"name":161,"class":44},"Centre for Infectious Disease Research in Zambia",1,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":162},"100455671","fontan-associated-liver-disease-and-the-evaluation-of-biomarkers-for-disease-severity-assessment-100455671","NCT05213598","Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment","Natural History of Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male and female subjects \\>= 18 years of age.\n2. Past surgical history of Fontan procedure.\n3. Prior enrollment in the Liver Diseases Branch protocol 91DK0214\n4. Underwent cardiac catheterization or transjugular liver biopsy within ten years prior to the date of screening\n5. Approved to proceed by the NIH Cardiology Consult\n6. Approved to proceed by the NIH Cardiac Pre-anesthesia Consult\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Evidence of other forms of liver disease that typically result in cirrhosis.\n2. Evidence of active Chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (\\>10,000 IU\u002FmL).\n3. Hepatitis C as defined by the presence of hepatitis C RNA in serum.\n4. Evidence of other liver disease such as primary sclerosing cholangitis, primary biliary cirrhosis, Wilson s disease, autoimmune hepatitis as defined by either liver histology or laboratory abnormalities.\n5. Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy or homozygosity for C282Y. Patients with iron saturation indices of \\>45% and serum ferritin levels of \\>300 ng\u002Fml for men and \\>250 ng\u002Fml for women will undergo genetic testing for hemochromatosis.\n6. Bile duct obstruction as suggested by imaging studies done within the previous six months.\n7. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year (assessed during patient interviews or by patient self-report).\n8. Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 50 ng\u002Fml (normal \\\u003C6.6 ng\u002Fml) and\u002For ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.\n9. Evidence of Cholangiocarcinoma.\n10. A documented or otherwise stated severe allergic reaction to contrast.\n11. Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.\n12. Radiation exposure exceeds 5 rems during the past year.\n13. Inability to comply or give written informed consent as there is no direct benefit from participation in this study.\n14. Female subjects who are currently pregnant will be excluded due to radiation exposure necessary for study completion. In addition, altered hemodynamics may confound the study s results. Following pregnancy, patients may be reconsidered for the study.","100 Years",{"count":172,"type":22},100,"Background:\n\nIn Fontan Associated Liver Disease (FALD), congestion of blood in the liver causes cirrhosis. This condition can cause death. Researchers want to understand what triggers this process and find new treatments for it.\n\nObjective:\n\nTo understand how long-term congestion of blood in the liver causes liver scarring that eventually leads to cirrhosis.\n\nEligibility:\n\nPeople aged 18 and older who are at risk of developing FALD from the Fontan procedure.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nLiver ultrasound. This uses sound waves to take pictures of the body.\n\nParticipants will have an outpatient visit within 12 weeks after screening. Within 24 weeks later, they will have a 3-day hospital stay. About 2 weeks later, they will have a follow-up visit.\n\nVisits will include repeats of the screening tests and:\n\nHeart tests\n\nStool collection\n\nQuestionnaires\n\nMRI of the liver. Participants will lie on a bed that slides in and out of the scanner. They will receive a contrast agent injected into a vein. While in the scanner, they will also have an MRCP to view the bile ducts and the pancreatic duct.\n\nFibroscan exam. This is an ultrasound that uses a special probe to look at the toughness of the liver.\n\nUpper endoscopy. This uses a thin scope to look inside the upper digestive tract.\n\nLiver biopsy. This will be taken through large vein in the neck or through the chest. Just before the biopsy, participants will have pressure measurements inside their liver. For this, a catheter will be inserted into a neck vein and guided into the liver.",[28],[176,177],"Cardiac Hepatopathy","Natural History","2026-07-30",{"date":180,"type":37},"2026-07-31",{"date":182,"type":37},"2022-09-07",{"date":184,"type":22},"2051-06-30",{"name":186,"class":187},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":196,"conditions":197,"keywords":206,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":162},"100599224","longitudinal-validation-of-circ-technologies-100599224","NCT07081711","Longitudinal Validation of CIRC Technologies","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Vulnerable populations will be excluded from this study including Prisoners\n* Other contraindications to CMR imaging to be determined by standard MRI protocols\n* Decisionally impaired (e.g., dementia or cognitive disability)",{"count":195,"type":22},1000,"Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases.\n\nThe study team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.",[198,111,199,200,201,202,28,203,204,205],"Cardiovascular Diseases","Ischemic Heart Disease","Non-ischemic Cardiomyopathy","Valvular Heart Disease","Metabolic Cardiomyopathy","Aortic Diseases","Atrial Fibrillation","Ventricular Fibrillation",[207],"MRI","2026-07-29",{"date":180,"type":37},{"date":211,"type":37},"2026-05-06",{"date":213,"type":22},"2037-08",{"name":215,"class":44},"The Cleveland Clinic",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":227,"conditions":228,"keywords":232,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":71},"100570778","prenatal-maternal-mental-health-and-neurodevelopment-in-congenital-heart-disease-100570778","NCT06711666","Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease","Prenatal Maternal Mental Health and Neurodevelopment in Children With an Antenatal Diagnosis of Congenital Heart Disease: The Neuro-Moms CHD Study","Neuro-Moms","Inclusion Criteria for the mother of a child diagnosed with CHD:\n\n1. Age at least 18 years old\n2. Expecting women\n3. Having received a diagnosis of foetal critical cyanotic CHD (i.e., CHD physiology that can compromise blood oxygenation after birth). This type of CHDs corresponds to the highest level of neurological risk as reported by the American Heart Association guidelines(1).\n4. Pregnancy of at least 28 weeks of gestation (third trimester) and up to the 38 weeks of gestation at the time of enrolment and prenatal visit for the study.\n5. Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux).\n6. A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease.\n7. Social security affiliation in France.\n\nInclusion criteria for the father or co-parent:\n\n1. Co-parent of an expecting woman participating in the study\n2. Age at least 18 years old\n3. Social security affiliation in France.\n\nInclusion criteria for the child diagnosed with congenital heart disease:\n\n1. Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study\n2. Written consent from both parents\n3. Social security affiliation in France.\n\nNon-inclusion Criteria for mothers:\n\n1. Patient refusal to participate\n2. Participants (i.e., expecting women) who express a wish for medical termination of pregnancy\n3. Diagnosis of a complex CHD associated with another foetal comorbidity with a clinically recognized impact on neurodevelopment (e.g., genetic syndromes such as trisomies, poly-malformation syndromes).\n4. Participants who are not able to understand the instructions and\u002For complete the self-reports\n5. Expecting women who currently have a major psychiatric condition (e.g., untreated major depression, severe anxiety disorders, psychotic disorders) with or without treatment, at the time of the cardiology consultation or at the time of the first psychological evaluation. Patients who will be excluded due to these conditions will be referred for perinatal psychiatric consultation.\n6. Persons under legal or judicial guardianship.\n\nNon-inclusion Criteria for fathers or co-parents:\n\n1. Patient refusal to participate\n2. Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment\n3. Persons under legal or judicial guardianship.\n\nExclusion Criteria for the mother of a child diagnosed with CHD:\n\n1\\. The child has not undergone surgery within 60 days of birth.\n\nExclusion Criteria for children with CHD:\n\n1\\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.","50 Years",{"count":226,"type":22},174,"Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.",[28,229,230,231],"Cyanotic Congenital Heart Disease","d-Transposition of the Great Arteries","Hypoplastic Left Heart Syndrome",[233,234,235,236,237],"psychological stress","Maternal prenatal mental health","Neurodevelopment","Cyanotic congenital heart disease","Prenatal diagnosis",{"date":178,"type":37},{"date":240,"type":37},"2025-06-27",{"date":242,"type":22},"2029-02",{"name":244,"class":245},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":261,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":162},"100649210","evaluating-a-wireless-nirs-device-in-the-neonatal-intensive-care-unit-100649210","NCT07732244","Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit","Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit: a Sub-study of the Wireless NICU Study","Inclusion Criteria:\n\n* Infants admitted to the NICU with a gestational age of ≥ 32 weeks at the time of the monitoring\n* undergoing monitoring with the INVOS wired NIRS system.\n\nExclusion Criteria:\n\n* Infants with a skin abnormality that would potentially increase the risk of injury,\n* Patient too unstable or family experiencing too much stress as determined by an attending physician or bedside care team to not be approached for recruitment.",{"count":254,"type":22},20,[25],"The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days. As standard-of-care, nursing personnel removes all sensors at every care to evaluate skin and reduce the risk of pressure sores. The wireless NIRS device will be removed and reapplied at the same time, by the research team who will annotate what time the sensor was removed, replaced, and the condition of the skin. This will be used to correlate signal disconnection with sensor care (i.e., skin checks, sensor removal, etc.).",[258,28,259,260],"Hypoxic-Ischemic Encephalopathy","Stroke Hemorrhagic","Aneurysm Cerebral",[262,263,264,265,266],"NIRS","Near-Infrared Spectroscopy","Wireless Sensor","Technology","NICU",{"date":268,"type":37},"2026-07-28",{"date":270,"type":37},"2025-11-15",{"date":272,"type":22},"2026-12-01",{"name":274,"class":44},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":162},"100647222","observational-data-collection-for-blood-hemoglobin-algorithm-validation-in-pediatrics-100647222","NCT07706140","Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics","Prospective Observational Data Collection Study for Validation of a Near-Infrared Spectroscopy-Based Blood Hemoglobin Algorithm in Pediatric Patients Undergoing Cardiac Surgery or Cardiac Catheterization","Inclusion Criteria:\n\n1. Age less than 21 years at the time of enrollment.\n2. Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia.\n3. Placement of an arterial catheter as part of routine clinical care for the procedure.\n\nExclusion Criteria:\n\n1. Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality.\n2. Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.","0 Days","21 Years",{"count":172,"type":22},"This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin measurements obtained from blood samples that are already being collected as part of routine medical care.\n\nThe goal of the study is to determine whether a blood hemoglobin monitoring method that has already been cleared by the U.S. Food and Drug Administration (FDA) for use in adults may also work well in pediatric patients.",[287,288,28],"Hemoglobin","Cerebral Oxygenation",[290,291,292,293,294,295,296,297,298,299],"pediatric cardiac surgery","pediatric cardiac catheterization","transfusion guidance","noninvasive hemoglobin monitoring","near-infrared spectroscopy NIRS monitoring","tissue oximetry","ForeSight system","HemoSphere monitor","algorithm validation","arterial blood gas comparison","2026-07-24",{"date":90,"type":37},{"date":303,"type":22},"2026-08",{"date":305,"type":22},"2027-12",{"name":307,"class":44},"Boston Children's Hospital",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":330,"leadSponsor":332,"locationsCount":4},"100645610","exercise-prehabilitation-in-congenital-heart-disease-100645610","NCT07700459","Exercise Prehabilitation in Congenital Heart Disease","A Randomised-controlled Trial to Assess the Impact of Prehabilitation and a Structured Exercise Programme on Cardiorespiratory Performance in Adults Awaiting Elective Surgery for Congenital Heart Disease: The ACE-CHD Trial.","ACE-CHD","Inclusion Criteria:\n\n* Adults with congenital heart disease requiring cardiac surgery via sternotomy or thoracotomy.\n* Capacity to provide informed consent.\n* Ability and willingness to engage in exercise-based interventions.\n* Peak VO2 \\\u003C30ml\u002Fkg\u002Fmin at preoperative exercise assessment.\n* Participant reached peak VO2 in preoperative exercise assessment (RER \\>1.0).\n* Ability to communicate in English.\n\nExclusion Criteria:\n\n* Surgery is scheduled for a date that precludes participation in the programme - surgical date is \\\u003C9 weeks away.\n* Pregnancy of \\\u003C6 months postpartum.\n* History of pneumothorax within the last 3 months.\n* Resting oxygen saturations \\\u003C94%.\n* Uncorrected right-to-left shunt with exercise.\n* Fontan physiology.\n* Pulmonary hypertension.\n* Critical valvular obstruction.\n* Sustained ventricular arrhythmia.\n* Severe aortic dilatation (\\>45mm in Marfan syndrome or hereditary aortopathy, \\>50mm in bicuspid or tricuspid aortic valves).\n\nThe oldest person operated upon by the ACHD service was 78 years old. Upper age is not an exclusion criteria.",{"count":317,"type":22},32,[25],"Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD).\n\nThanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood.\n\nAs people with CHD get older, many need repeated heart operations. It is known from other areas of medicine that \"prehabilitation\" - a short, structured exercise programme completed before surgery - can improve fitness and help patients cope better with major operations. However, this approach has never been tested in adults with CHD. The investigators are running a randomised controlled trial to find out whether a prehabilitation programme can improve physical fitness before heart surgery in adults with CHD.\n\nParticipants will be randomly assigned to usual care or a prehabilitation group. Those in the prehabilitation group will follow a tailored, supervised exercise plan for several weeks before surgery.\n\nAll patients undergoing cardiac surgery routinely complete a cardiopulmonary exercise test (CPET) as part of their standard pre-operative assessment. CPET is a well-established test that shows how the heart and lungs respond to increasing levels of exercise. During the test, participants exercise on a bike while their breathing, heart rate, and overall physiological response are continuously monitored.\n\nThe results of each participant's routine CPET will be used to guide the individualised exercise programme in the intervention group.\n\nExercise levels prescribed in the study will not exceed the intensity already safely achieved during the routine CPET, ensuring that activity remains within clinically assessed limits.\n\nParticipants in the trial will complete an additional second CPET following the trial period.\n\nThe key question is whether a tailored exercise programme can improve fitness in adults with CHD before heart surgery, and whether this approach is feasible, acceptable and practical to deliver, including successful recruitment and measurable physiological improvements.",[28,321],"Cardiac Surgery",[323,324,325],"Congenital heart disease","Prehabilitation","Cardiac surgery","2026-07-21",{"date":328,"type":37},"2026-07-22",{"date":88,"type":22},{"date":331,"type":22},"2029-06-01",{"name":333,"class":44},"Liverpool Heart and Chest Hospital NHS Foundation Trust",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":342,"maxAge":53,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":346,"conditions":347,"keywords":354,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":162},"100648054","screening-for-disorders-of-lipid-metabolism-and-familial-hyperlipidemia-in-children-and-adolescents-with-increased-cardiovascular-risk-due-to-chronic-diseases-such-as-congenital-heart-disease-chronic-inflammatory-bowel-disease-celiac-disease-and-rheumatic-disorders-100648054","NCT07716488","Screening for Disorders of Lipid Metabolism and Familial Hyperlipidemia in Children and Adolescents With Increased Cardiovascular Risk Due to Chronic Diseases Such as Congenital Heart Disease, Chronic Inflammatory Bowel Disease, Celiac Disease and Rheumatic Disorders","Screening Auf Lipidstoffwechselstörungen Und familiäre Hyperlipidämien Bei Kindern Und Jugendlichen Mit erhöhtem kardiovaskulären Risiko Durch Chronische Erkrankungen Wie Angeborene Herzfehler, Chronisch entzündliche Darmerkrankungen, Zöliakie Sowie Rheumatische Erkrankungen","FAMELIPIDCHILD","Inclusion Criteria: Patients aged 5 to 18 years who are being treated at the UKJ in one of our specialized pediatric clinics for a chronic condition-such as a congenital heart defect, chronic inflammatory bowel disease, celiac disease, or a rheumatic disease.\n\nExclusion Criteria: Lack of consent from the patient or legal guardian(s)","6 Years",{"count":344,"type":22},600,[25],"Preventive measures are increasingly coming to the forefront of medicine. Many of these measures can be implemented as early as childhood and adolescence. For instance, the early detection and treatment of cardiovascular risk factors can significantly reduce long-term morbidity and mortality associated with cardiovascular diseases such as heart attack and stroke. For years, there has been discussion in Germany about assessing lipid profiles during childhood and adolescence to enable early intervention in cases of conditions like familial hypercholesterolemia. However, comprehensive screening has not yet been established in either clinical guidelines or routine practice. In other countries, such as Norway, universal screening has been conducted for many years and has already demonstrated both its benefits and cost-effectiveness. In Germany, screening, and subsequent early treatment if needed, is currently limited to a small number of children and adolescents-such as patients with type 1 diabetes mellitus (T1DM)-as part of their routine preventive check-ups. The prevalence of dyslipidemia in T1DM is approximately 15%. Reliable prevalence data are lacking for almost all other chronic conditions affecting children and adolescents (e.g., inflammatory bowel disease, celiac disease, rheumatic diseases, congenital heart defects). Through a pilot project at Jena University Hospital, we aim to screen children and adolescents with chronic conditions who are already at increased cardiovascular risk due to their underlying diseases. The project will record lipid levels, clinical data, family history, and lifestyle factors. The results of this study enable us, on the one hand, to help the individual through early diagnosis and consequent treatment recommendations; on the other hand, the data provide important information regarding the prevalence of hyperlipidemia and other risk factors-such as physical inactivity-within this high-risk cohort.",[348,349,28,350,351,352,353],"Lipid Metabolism Disorders","Lipid Metabolism, Inborn Errors","Inflammatory Bowel Disease (IBD)","Rheumatic Diseases","Celiac Disease in Children","Celiac Disease in Adolescents",[355,356,357,358],"lipid metabolism disorders","chronic disease","children","adolescents","2026-07-16",{"date":326,"type":37},{"date":362,"type":22},"2026-08-01",{"date":364,"type":22},"2027-04-30",{"name":366,"class":44},"Alexandra Miriam Kiess",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":162},"100506087","hfnc-vs-nippv-following-extubation-100506087","NCT05869825","HFNC vs NIPPV Following Extubation","High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation Following Extubation in Infants After Cardiac Surgery for Congenital Heart Disease: A Randomized Clinical Trial","Inclusion Criteria:\n\n* All patients admitted to the CICU following cardiac surgery for CHD who are \\\u003C\u002F= 1 year of age and\u002For weight \\\u003C\u002F= 10 kg\n\nExclusion Criteria:\n\n* Patients who remain intubated for \\>\u002F= 4 weeks\n* Patients who have a tracheostomy prior to their cardiac surgery\n* Patient enrolled in a competing research study\n* Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively\n* Patients with birth weight \\\u003C 2 Kg.\n* Gestational age \\\u003C 35 weeks at birth.\n* Patients with extracardiac anomalies more than minor severity.","1 Year",{"count":376,"type":22},200,[25],"This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes.\n\nThis study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure.\n\nBoth study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.",[28],[381,382],"Cardiac surgery for CHD","Cardiac Intensive Care Unit","2026-07-12",{"date":385,"type":37},"2026-07-14",{"date":387,"type":37},"2025-02-27",{"date":389,"type":22},"2027-03",{"name":391,"class":44},"Emory University",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":162},"100645972","interoceptive-intervention-for-congenital-heart-disease-100645972","NCT07697755","Interoceptive Intervention for Congenital Heart Disease","A Randomised Controlled Feasibility Trial Exploring an Interoceptive-Based Intervention in Patients With Congenital Heart Disease","Inclusion Criteria:\n\n* Participants must be aged 18 years or older\n* Under the care of the Scottish Adult Congenital Cardiac Service (SACCS) at the Golden Jubilee University National Hospital (GJUNH)\n* Be able to understand and communicate in English\n* Provide informed consent\n* Access and use a device compatible with Microsoft Teams\n* Be able to commit to the duration of the group programme\n\nExclusion Criteria:\n\n* Individuals with current suicidal ideation\n* Individuals with comorbid alcohol or substance use disorders\n* Individuals with a diagnosed learning disability\n* Individuals with a severe and enduring mental health condition (e.g., personality disorder or psychosis)\n* Individuals with hearing, visual and cognitive difficulties preventing safe online group participation\n* Individuals who are currently on a surgical or transplant waiting list\n* Individuals who are receiving intensive psychological treatment (e.g., trauma processing or crisis support)",{"count":317,"type":22},[25],"Adults living with congenital heart disease (CHD) commonly experience physical symptoms alongside emotional and social challenges, which can affect wellbeing and health-related quality of life. Access to psychological services varies, and evidence to guide the development and delivery of psychological interventions for this population is still emerging.\n\nInteroceptive-based approaches focus on increasing awareness of and responding adaptively to internal bodily sensations, such as breathing, heart rate and fatigue. These approaches have shown benefits in other long-term health conditions but have not yet been studied in adults with CHD. This study will evaluate the feasibility, acceptability, and preliminary effects of a newly adapted online, skills-based group programme for adults with CHD.\n\nThirty-two participants will be recruited through the Scottish Adult Congenital Cardiac Service and randomly allocated to one of two cohorts: Cohort 1 (Immediate Intervention) and Cohort 2 (Delayed\u002FWaitlist Intervention). The group programme will consist of eight online sessions delivered by a Principal Clinical Psychologist and a Trainee Clinical Psychologist. Weekly sessions will explore the relationship between interoception and key areas relevant to living with CHD, including emotions, behaviours, and physical symptoms. Group discussions and exercises will focus on increasing awareness and understanding of internal bodily sensations, developing strategies for responding to interoceptive cues and using bodily information to guide behaviours and everyday activities.\n\nParticipants will complete online questionnaires before and after the intervention assessing interoception, anxiety, depression and health-related quality of life. Participants will also provide feedback regarding the acceptability and perceived usefulness of the programme. Participation is voluntary, and participants may withdraw at any time without affecting their clinical care. Appropriate emotional support will be available should participants experience distress related to the group materials or discussions.\n\nFindings from this feasibility randomised controlled trial will inform further refinement of the group programme, assess the acceptability and feasibility of study procedures, provide estimates of recruitment, retention and outcome variability, and support the design and sample size calculation of a future definitive trial. The findings may also contribute to the enhancement of psychological support for adults with CHD and be disseminated through scientific publications and conference presentations.",[403,28],"Interoception",[405,403,406,407,408,409],"Adult Congenital Heart Disease","Psychological Intervention","Group Intervention","Pilot Study","Feasibility Randomised Controlled Trial","2026-07-08",{"date":412,"type":37},"2026-07-13",{"date":414,"type":22},"2026-07",{"date":416,"type":22},"2026-12",{"name":418,"class":44},"University of Glasgow",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":426,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100490746","neuro-cardiac-rehabilitation-in-youth-with-congenital-heart-disease-qualineurorehab-100490746","NCT05670132","Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)","Impact of a Neuro-cardiac Rehabilitation Program on the Quality of Life of Children, Adolescents, and Young Adults With Congenital Heart Disease: the Multicentre Randomized Controlled QUALINEUROREHAB Trial","Inclusion Criteria:\n\n1. Patient with a CHD of moderate to great complexity as defined in the 2019 AHA\u002FACC guidelines (Appendix 2)85.\n2. History of cardiac surgery and\u002For catheter-based cardiac intervention(s) during the first year of life.\n3. Age between 8 and 25 years at the time of enrolment.\n4. Parental or legal guardian's consent for minors (\\\u003C18 years) and personal consent for adults.\n5. Social security affiliation (for France only)\n\nExclusion Criteria:\n\n1. Unstable and\u002For severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring hospitalisation and\u002For any significant change in medication (\\\u003C 3 months before enrolment), systolic ventricle dysfunction (left ventricle or systemic ventricle ejection fraction \\\u003C 50%)82.\n2. Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \\\u003C85%, and\u002For SpO2 at exercise \\\u003C80%, and\u002For patient requiring oxygen therapy.\n3. Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83.\n4. Significant systolic right ventricle (sRV) hypertension (sRV pressure \\> 50% of systemic systolic pressure).\n5. Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and\u002For exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and\u002For CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and\u002For CPET.\n6. Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and\u002For CPET.\n7. Uncontrolled arterial hypertension at rest (e.g. if the blood pressure at rest during the consultation \\>140\u002F90 mmHg in adults, \\>95th percentile in children84).\n8. Acute or recent (\\\u003C 3 months) myocarditis and pericarditis.\n9. Symptomatic aortic or sub-aortic stenosis (mean gradient \\> 50 mmHg).\n10. Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient \\> 20 mmHg.\n11. Dilatation of the aorta (aortic root \\> 40 mm in adults, \\> 2 Z-score in children85 (http:\u002F\u002Fwww.parameterz.com\u002Fsites\u002Faortic-root) except in the case of repaired congenital heart disease with dilatation of the aorta inherent in the malformation and without significant risk of aortic dissection (tetralogy of Fallot, pulmonary atresia with VSD, transposition of the great arteries, truncus arteriosus, double outlet right ventricle, or single ventricle).\n12. Severe hypertrophic obstructive cardiomyopathy.\n13. Acute systemic illness.\n14. Recent (\\\u003C3 months) intracardiac thrombus, embolism, or thrombophlebitis.\n15. Inability to follow instructions and\u002For complete the questionnaires, as determined by the investigator.\n16. Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and patients with mental impairment leading to inability to cooperate.\n17. Inability to undergo the physical intervention: inability to physically exercise, any invasive medical intervention occurring within 6 months preceding the enrolment or scheduled during the 12-month study period (such as cardiac surgery, catheter-based intervention, orthopaedic surgery, chemotherapy for cancer, or any other significant medical treatment or intervention, as determined by the investigator).\n18. Patient with a previously diagnosed or suspected severe psychiatric disorder (major depression with or without suicidal ideation, psychotic diagnoses, severe anxiety \u002Fpanic disorders) requiring hospitalization and\u002For continuous specialized care by a psychiatrist, as determined by the investigator.\n19. Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment.\n20. Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment.\n21. For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient.\n22. Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent.\n23. Any other clinical and\u002For pharmacological treatment that is believed to interfere with the study or the optimal clinical care.\n24. Initiation or total withdrawal of psychotropic medication (i.e., any psychotropic medication including methylphenidate, benzodiazepines, and mood stabilizers) within the 6 months preceding the enrolment.\n25. Patient participating or wishing to participate in any interventional clinical research (drug trial, medical device, non-drug trial).","8 Years","25 Years",{"count":429,"type":22},192,[25],"Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular\u002Fphysical variables.",[28],[434,435],"Neuro-cardiac rehabilitation program","Quality of life","2026-07-07",{"date":410,"type":37},{"date":439,"type":37},"2024-06-03",{"date":441,"type":22},"2028-06-03",{"name":443,"class":44},"University Hospital, Bordeaux",6,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":453,"targetDuration":455,"studyType":56,"phases":4,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":162},"100427656","the-patients-presenting-with-congenital-heart-disease-register-artoria-r-100427656","NCT04848844","The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)","The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R): A Global Register to Investigate Factors Associated With Morbidity and Mortality in Adult Patients With Congenital Heart Disease (ACHD) on the Waiting List for Heart or Heart\u002FLung Transplantation","ARTORIA-R","Inclusion Criteria:\n\n1. The patient has to be listed as an adult transplant candidate in the country the data is obtained with an age ≥18 years\n2. The patient has to have a congenital heart defect or an inherited cardiomyopathy (specific; hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy or non-compaction cardiomyopathy) which is often included into the category ACHD\n3. Data is obtained from the first evaluation for listing or listing for heart-only or heart-combined organ transplantation\n4. Transfer of anonymised data\n5. The institution\u002Forganization agrees to the memorandum how data is managed, and scientific cooperation is planned between all institutions\n\nExclusion Criteria:\n\na. The patient is listed for a second heart transplantation (retransplantation)",{"count":454,"type":22},2000,"30 Years","Advances in surgical and medical care have led to improved outcomes in patients with congenital heart disease (CHD). As a consequence, the majority of patients nowadays survives to adulthood (adults with CHD, that is, adult CHD \\[ACHD\\]) with good quality of life. Despite the surgical success, the morbidity and mortality of ACHD is higher than in the general population and is linked to the development of heart failure (HF) in adulthood.\n\nHF occurs in approximately 25% of patients with ACHD, even in those patients in whom the congenital mal-formation has been corrected successfully in childhood. The time course and presentation are heterogeneous owing to variable congenital malformation and limitation of treatment options. ACHD with an anatomic right ventricle as the systemic ventricle (e.g., atrial switch operation in patients with transposition of the great arteries \\[TGAs\\]) and those with a functional single ventricle (e.g., Fontan circulation) appear to be at higher risk of developing HF. Young age at initial corrective surgery-often in the first 2 years of life-and lack of specific medical therapies can contribute to a high and early demand for heart transplantation in patients with ACHD.",[28,111,458,459,460],"Transplant; Complication, Failure","Arrythmia","Ventricular Dysfunction","2026-06-28",{"date":463,"type":37},"2026-07-01",{"date":465,"type":37},"2020-09-02",{"date":467,"type":22},"2030-07-30",{"name":469,"class":44},"Universitätsklinikum Hamburg-Eppendorf",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":478,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":481,"conditions":482,"keywords":486,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":495,"leadSponsor":497,"locationsCount":162},"100644448","wearable-assessment-of-thoracic-cardiac-health-and-exercise-performance-trial-prospective-100644448","NCT07663799","Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective","Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective (WATCH-XP)","WATCH-XP","Inclusion Criteria:\n\n* Age 20 to 70 years old\n* Ability to provide informed consent\n* History of the following cardiovascular conditions:\n* Adult congenital heart disease\n* Pulmonary hypertension\n* Heart failure\n* Coronary artery disease\n* Athletes undergoing cardiovascular assessment\n\nExclusion Criteria:\n\n* Contraindication for undergoing physical exertion including cardio-pulmonary exercise testing (CPX) and 6-minute walk test (6MWT)\n* Pregnancy\n* Known allergy to components of the investigational product","20 Years","70 Years",{"count":254,"type":22},"Wearable health technology, particularly smartwatches, has revolutionized personal health monitoring by enabling continuous, non-invasive tracking of various physiological parameters. The potential applications of these devices in cardiology are extensive, but it is crucial to validate their accuracy against established medical-grade devices.\n\nThe Apple Watch Series 9 (Apple, USA) exemplifies the capabilities of modern smartwatches, offering a wide range of health tracking features. These include heart rate monitoring, detection of irregular heart rhythms suggestive of atrial fibrillation, electrocardiogram recording, blood oxygen level measurement, and comprehensive mobility metrics (including VO2 max, six-minute walk distance, walking speed, step length, double support time, and walking asymmetry). Many of these parameters are highly relevant for cardiovascular patients, potentially aiding in disease progression monitoring and adverse event prediction. However, there is a lack of comprehensive validation studies for these devices in specific cardiovascular disease populations.\n\nThis investigator-initiated, prospective observational study will consist of two phases: a training phase which involves 50 participants and a prospective validation phase which involves 20 participants. The study aims to validate smartwatch-based assessments using medical-grade devices and techniques. The study will focus on adult patients with congenital heart disease, pulmonary hypertension, heart failure, and coronary artery disease, as well as athletes undergoing cardiovascular assessment. By comparing smartwatch data with established clinical measurements, we seek to determine the reliability and potential clinical utility of these wearable devices in diverse cardiovascular contexts. Anonymized smartwatch data collected during the two phases will be published to a publicly registry to facilitate further research. This research will help bridge the gap between consumer-grade wearable technology and clinical practice in cardiology.",[28,483,111,484,485],"Pulmonary Hypertension","Coronary Heart Disease (CHD)","Apple Watch",[487,488,117,489,490],"apple watch","congenital heart disease","coronary heart disease","pulmonary hypertension","2026-06-16",{"date":493,"type":37},"2026-06-23",{"date":362,"type":22},{"date":496,"type":22},"2028-12-31",{"name":498,"class":44},"The University of Hong Kong",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":52,"sex":17,"minAge":505,"maxAge":506,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":523},"100488261","dynamic-critical-congenital-heart-screening-with-addition-of-perfusion-measurements-100488261","NCT05637814","Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements","Inclusion Criteria:\n\n* Age \\\u003C 22 days\n* Fetuses suspected to have congenital heart disease\n* Newborns with suspected\u002Fconfirmed critical congenital heart disease\n* Asymptomatic newborn undergoing SpO2 screening for CCHD\n\nExclusion Criteria:\n\n* Echocardiogram completed prior to enrollment as the newborn would then no longer be considered \"asymptomatic undergoing SpO2 screening for CCHD\"\n* For Newborns with confirmed\u002Fsuspected congenital heart disease (CHD): a) Patent ductus arteriosus and\u002For atrial septal defect\u002Fpatent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.","0 Minutes","21 Days",{"count":508,"type":22},320,[25],"The purpose of this study is to implement and externally validate an inpatient ML algorithm that combines pulse oximetry features for critical congenital heart disease (CCHD) screening.",[28],[513,514],"Machine Learning Algorithm","Pulse Oximetry",{"date":516,"type":37},"2026-06-18",{"date":518,"type":37},"2023-08-17",{"date":520,"type":22},"2027-12-31",{"name":522,"class":44},"University of California, Davis",3,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":162},"100559457","tailored-mgso4-supplementation-to-reduce-complications-in-pediatric-heart-surgery-100559457","NCT06564376","Tailored MgSO4 Supplementation to Reduce Complications in Pediatric Heart Surgery","Individually Tailored MgSo4 Supplementation to Reduce Cardiac and Renal Complications in Pediatric Heart Surgery","Inclusion Criteria:\n\n* Children undergoing cardiac surgery utilizing cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Children undergoing cardiac surgery without cardiopulmonary bypass\n* Children with Renal disease\n* Children with pre-existing arrhythmia\n* Children on anti-arrhythmia medication",{"count":532,"type":22},96,[25],"Lay Summary\n\nThis study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems after surgery. The right amount of magnesium in blood reduces this risk. This study will test the best way to measure magnesium. This will let doctors choose the right dose of MgSO4. MgSO4 is a magnesium supplement. Taking MgSO4 after heart surgery helps children. For each child, it is best to personalize MgSO4 dose. This is based on the amount of magnesium in blood. This study will test two ways of personalizing MgSO4 dose.\n\nIn the blood, there are two kinds of magnesium. Usually, blood magnesium tests measure both forms together. This does not say anything about active magnesium. This study will measure the two forms separately. Then, MgSO4 will be given based on either the active or whole magnesium. Measuring active magnesium is good. Active magnesium levels change faster than total. That means active magnesium tests may better protect children. Also, active magnesium has more of an impact on heart and kidney function. Focusing on the active form will help these organs stay healthy.\n\nTo test how well the MgSO4 is working, heart and kidneys will be examined. After surgery, certain harmful heart rhythms can occur. The types and number of harmful rhythms will be studied. Kidney problems can also happen after heart surgery. Kidney health will be studied. To help understand how active magnesium works, further tests will be done. These tests will look for evidence of poor health in the cells that make up the heart, kidney, and blood.",[536,459,28],"AKI - Acute Kidney Injury",[538,539,540,541],"Acute Kidney Injury","Arrhythmias","Congenital heart surgery","Cardiopulmonary bypass","2026-06-12",{"date":491,"type":37},{"date":362,"type":22},{"date":546,"type":22},"2029-06",{"name":548,"class":44},"West Virginia University",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":426,"maxAge":53,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":577,"leadSponsor":579,"locationsCount":162},"100637735","exergame-based-physical-activity-promotion-for-children-and-adolescents-with-congenital-heart-disease-100637735","NCT07593118","Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease","An Exergame-Based Physical Activity Promotion Intervention for Children and Adolescents With Congenital Heart Disease: A Multiple-Baseline Single-Case Experimental Design Study","ExPACE-CHD","Inclusion Criteria:\n\n1. aged 8-18 years, with a confirmed diagnosis of congenital heart disease and a history of cardiac surgery or catheter-based intervention;\n2. at least 3 months since the most recent surgery or intervention, with a clinically stable condition and no planned reintervention in the near future;\n3. deemed by a pediatric cardiologist to be suitable for regular physical activity or low-to-moderate to moderate-to-vigorous physical activity;\n4. presenting with insufficient physical activity and\u002For impaired exercise capacity, defined by at least one of the following: failure to meet the recommended physical activity level for children and adolescents (ie, an average of 60 minutes of moderate-to-vigorous physical activity per day), objectively impaired exercise capacity (eg, peak oxygen uptake \\\u003C80% of predicted and\u002For anaerobic threshold \\\u003C55% of predicted), or reduced exercise tolerance indicated by the 6-minute walk test, physical fitness assessment, or clinical exercise evaluation;\n5. having basic cognitive and communication abilities sufficient to understand instructions and complete questionnaires, trial sessions, and training tasks;\n6. willingness of both the child and the guardian to participate, with written informed consent obtained;\n7. availability of basic family conditions to support intervention delivery, including access to smart devices and\u002For game equipment, internet access, and at least one caregiver able to provide support.\n\nExclusion Criteria:\n\n1. clear contraindications to exercise, such as uncontrolled arrhythmia, overt heart failure, severe pulmonary hypertension, or recent hemodynamic instability;\n2. severe comorbidities that substantially interfere with exercise performance, such as serious neurological disorders, severe musculoskeletal disorders, or other conditions markedly limiting physical activity;\n3. participation within the previous 3 months in another systematic intervention likely to substantially influence physical activity or exercise capacity;\n4. any condition, as comprehensively judged by the research team, that may affect participant safety, intervention implementation, the quality of physical activity monitoring data, or completion of questionnaires or follow-up, including refusal to wear the monitoring device, refusal to complete follow-up, or evident risk of poor adherence.",{"count":558,"type":22},13,[25],"The goal of this clinical trial is to learn whether a Nintendo Switch-based exergame physical activity program can help children and adolescents with congenital heart disease increase their physical activity. It will also learn about the safety, acceptability, and feasibility of this program. The study will include children and adolescents aged 8 to 18 years who have congenital heart disease, have received surgical or interventional treatment, and are clinically stable.\n\nThe main questions it aims to answer are:\n\nDoes the exergame-based program increase the amount of time participants spend in moderate-to-vigorous physical activity each day? Is the exergame-based program safe, acceptable, and feasible for children and adolescents with congenital heart disease?\n\nAll participants will receive the same exergame-based physical activity program. Researchers will use different baseline observation periods to help understand whether changes in physical activity happen after the program starts.\n\nParticipants will:\n\nWear an activity monitor to measure daily physical activity. Complete a baseline observation period lasting 7, 14, or 21 days. Take part in a 12-week Nintendo Switch-based exergame physical activity program with guidance, goal setting, self-monitoring, feedback, and caregiver support.\n\nComplete a 2-week observation period after the program to see whether physical activity changes are maintained.\n\nComplete study assessments at screening, the end of baseline, week 4, week 8, week 12, and the end of the observation period.\n\nResearchers will also collect information on step counts, energy expenditure, self-reported physical activity, exercise capacity, quality of life, adherence, acceptability, and adverse events.",[28,562],"Physical Inactivity",[564,565,566,567,568,569,570,571,28,572],"Exergame","Physical Activity","Moderate-to-Vigorous Physical Activity","Children","Adolescents","Single-Case Experimental Design","Multiple-Baseline Design","Nintendo Switch","Accelerometer","2026-05-15",{"date":575,"type":37},"2026-05-18",{"date":463,"type":22},{"date":578,"type":22},"2027-09-01",{"name":580,"class":44},"The Children's Hospital of Zhejiang University School of Medicine",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":589,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":598,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":606,"locationsCount":162},"100601793","effectiveness-of-high-energy-density-enteral-nutrition-for-enhancing-physical-growth-and-cognitive-brain-development-in-infants-with-congenital-heart-disease-100601793","NCT07115108","Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease","Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease: A Randomized Controlled Study","RCT","Inclusion Criteria:\n\n* Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations.\n* Age 0-6 months\n* Children with nutritional risks (defined by STRONGkids: Nutritional risk screening tool for children )\n* Artificial or mixed feeding\n* Open heart surgery under cardiopulmonary bypass\n* The guardians of the children voluntarily participate in this study and sign a written informed consent form before the surgery.\n\nExclusion Criteria:\n\n* Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative diagnosis of gastroesophageal reflux, genetic diseases related to growth restriction, and various syndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome)\n* Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can be divided into primary and secondary immunodeficiencies.\n* Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy).\n* Secondary or primary gastrointestinal infection symptoms such as abdominal distension and diarrhea after surgery.\n* Estimated stay time in the postoperative intensive care unit ≤ 2 days","0 Months","6 Months",{"count":592,"type":22},160,[25],"The purpose of this study is to compare the effect of high and ordinary energy density enteral nutrition for improving physical growth and brain cognitive development in infants with congenital heart disease after operation, as well as evaluate the safety of interventions.",[28,596,597],"Enteral Nutrition","Pediatrics",[323,599,597],"Enteral nutrition","2026-05-12",{"date":602,"type":37},"2026-05-13",{"date":604,"type":37},"2025-10-13",{"date":68,"type":22},{"name":607,"class":44},"Children's Hospital of Fudan University",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":616,"maxAge":617,"enrollmentInfo":618,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":620,"conditions":621,"keywords":623,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":162},"100566693","pda-for-kidneys-study-100566693","NCT06658496","PDA for Kidneys Study","Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study","PDA4K","Inclusion Criteria:\n\n* Delivered at \\\u003C32 weeks' gestation\n* ≤72 hours of age\n* Inpatient at Meriter Hospital, Inc. NICU\n* At least one parent\u002Fguardian is able to provide parental permission in English or Spanish\n\nExclusion Criteria:\n\n* Major congenital anomalies of kidney\n* Attending physician's discretion to not place NIRS sensors due to clinical concerns\n* In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life\n* Birth parent aged \\\u003C18","1 Minute","7 Days",{"count":619,"type":22},45,"The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.\n\nResearchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.",[622,28],"Patent Ductus Arteriosus",[624],"neonate",{"date":573,"type":37},{"date":627,"type":37},"2024-12-19",{"date":629,"type":22},"2027-05",{"name":631,"class":44},"University of Wisconsin, Madison",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":17,"minAge":374,"maxAge":639,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":648,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":523},"100639102","empowering-families-in-pediatric-cardiovascular-surgery-a-ram-based-approach-100639102","NCT07575451","Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach","Evaluation of a Nursing Program Based on Roy's Adaptation Model for Empowering Families of Children Aged 1 to 3 Years Post-Cardiac Surgery","Inclusion Criteria:\n\n* Families who agree to participate in the study and sign the informed consent form.\n* Families of children aged 1-3 years in the preoperative period who are scheduled to undergo cardiac surgery due to congenital heart disease.\n* Families who do not speak or read Turkish but will undergo cardiac surgery due to congenital heart disease will also be included in the study with the assistance of an interpreter.\n* Families who are over 18 years of age and have access to a mobile phone or internet at home.\n\nExclusion Criteria:\n\n* Exclusion criteria include the presence of additional congenital malformations, dysmorphic syndromes, chromosomal or endocrine disorders, severe infection, hypothyroidism, or any similar conditions that could lead to growth and developmental delay in the child, alongside congenital heart disease","3 Years",{"count":641,"type":22},80,[25],"The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children.\n\nThe primary questions the study aims to answer are:\n\nDoes the nursing program positively affect the physical growth of children, such as their height and weight?\n\nDoes the program improve children's scores on general development tests (Denver II)?\n\nDo parents' attitudes toward child feeding and their confidence in parenting skills increase?\n\nResearchers will divide participants into two groups:\n\nExperimental Group: Families who participate in the nursing education program and receive an informative booklet.\n\nControl Group: Families who only receive an informative booklet and continue with routine hospital follow-ups.\n\nThe researchers will compare these two groups to see if participating in the nursing program leads to better results for the children's development and the families' skills.\n\nParticipants will be asked to:\n\nAttend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up.\n\nMeet with the researcher at specific intervals (at 1, 2, 3, 6, 9, and 12 months) for one year to monitor the child's development (height, weight, head circumference) and skills.\n\nComplete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.",[28,645,646,647],"Postoperative Care","Child Development","Roy Adaptation Model-based Nursing Empowerment Program",[28,321,645,649],"Nursing Support Program","2026-05-08",{"date":600,"type":37},{"date":653,"type":22},"2026-06-15",{"date":655,"type":22},"2027-06-15",{"name":657,"class":44},"Cukurova University",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":17,"minAge":665,"maxAge":666,"enrollmentInfo":667,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":669,"conditions":670,"keywords":671,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":162},"100492065","application-of-a-clinical-decision-support-system-to-reduce-mechanical-ventilation-duration-after-cardiac-surgery-in-children-100492065","NCT05687292","Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children","Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery","Inclusion Criteria:\n\n* Children \\\u003C 12 years old\n* Post-cardiac surgery\n* Receiving mechanical ventilation for ≥ 48 hours in the Cardiac Intensive Care Unit at Boston Children's Hospital following surgery\n\nExclusion Criteria:\n\n* Premature infants (\\\u003C37 weeks' gestation)\n* Weight \\\u003C 2kg\n* Baseline ventilator (via tracheostomy) or noninvasive positive pressure dependence","1 Day","12 Years",{"count":668,"type":22},330,"The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD). The main question it aims to answer is:\n\n-What is the impact of a CDSS designed to facilitate weaning and discontinuation of MV on the duration of MV in post-operative congenital cardiac surgery patients?\n\nParticipants will be identified as eligible to initiate weaning from mechanical ventilation. Providers will decide whether or not to initiate weaning based on recommendations provided by the CDSS. Researchers will compare patients exposed to the CDSS with a historical cohort to see if the CDSS facilitated a decrease in MV duration.",[28],[672,488,673,674,675],"cardiac surgery","critical care","pediatrics","mechanical ventilation","2026-05-07",{"date":600,"type":37},{"date":679,"type":37},"2024-11-18",{"date":681,"type":22},"2027-03-01",{"name":307,"class":44},{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":691,"targetDuration":478,"studyType":56,"phases":4,"briefSummary":692,"conditions":693,"keywords":694,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":695,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":162},"100489526","development-of-circ-technologies-100489526","NCT05654272","Development of CIRC Technologies","Development of Cardiovascular Innovation Research Technologies","CIRC","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Provision of written informed consent\n* If not healthy volunteer, must be diagnosed with cardiovascular disease\n\nExclusion Criteria:\n\n* Vulnerable populations will be excluded from this study including Prisoners\n* Other contraindications to CMR imaging to be determined by standard MRI protocols\n* Decisionally impaired (e.g., dementia or cognitive disability)",{"count":195,"type":22},"Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow us the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases.\n\nOur team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.",[198,111,199,200,201,202,28,203,204,205],[207],{"date":650,"type":37},{"date":697,"type":37},"2022-09-09",{"date":699,"type":22},"2042-09-09",{"name":215,"class":44}]