Congenital Heart Disease

102

Review clinical trials related to Congenital Heart Disease. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)

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. Objective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine. Study Population All children \< 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. Methodology 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. Primary Endpoint: To 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. Secondary Endpoints: 1. Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours 2. PELOD-2 score on ICU admission, at 48 hours post ICU admission 3. ICU and hospital length of stay 4. ICU, hospital, and 28 days mortality 5. Mechanical - ventilation (MV) free days at day 6. Renal replacement therapy (RRT) free days at day 28 7. Vasopressors free days at day 28 8. Acute kidney injury 9. Bleeding complications 10. Post operative liver injury Data Collection: Blood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure . Duration: The study is expected to last 24 months.

Participants needed: 120
Trial details
Age: 0-17Biological sex: AllType: InterventionalSponsor: Norfaniza ZabidiUpdated: Aug 18, 2026
Eligibility criteria

Children (<18 years old at study inclusion) [+2]

Non-ability to gather informed consent from parents or legal representative. Enr... [+2]

Status: Recruiting

Research on Body Voice AI Recognition System for Children's Health Management

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.

Participants needed: 30,000
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUpdated: Aug 12, 2026Locations: 5
Eligibility criteria

Age 0~18 years old, gender is not limited [+4]

≥ 18 years old [+2]

Status: Recruiting

Autus Valve Continued Access Study (CAS)

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. The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject.

Participants needed: 36
Trial details
Age: 18-16Biological sex: AllType: InterventionalSponsor: Edwards LifesciencesUpdated: Aug 10, 2026Locations: 10
Eligibility criteria

Age 18 months to 16 years. [+9]

Subject requires valve replacement in a non-pulmonary position. [+18]

Status: Recruiting

Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

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: 1. 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. 2. 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 The main questions the Cardiohelp single-arm trial seeks to answer are: * What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? * Should the Cardiohelp device be FDA-cleared for children based on the results of the study? * What are the optimal performance specifications of the Cardiohelp device in children? The main questions the blood thinner randomized trial seeks to answer are: * Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device? * 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? Children 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. For 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. The study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).

Participants needed: 50
Trial details
Phase: Phase 2Age: 0-16Biological sex: AllType: InterventionalSponsor: Stanford UniversityUpdated: Aug 10, 2026Locations: 5
Eligibility criteria

Age 0 to 16 years of age (i.e., <17 years) [+4]

Gestationally-corrected age <37 weeks [+11]

Status: Recruiting

Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System

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.

Participants needed: 2,084
Trial details
Biological sex: AllType: ObservationalSponsor: Centre for Infectious Disease Research in ZambiaUpdated: Aug 7, 2026Locations: 1Duration: 1 Month
Eligibility criteria

Presenting with chronic NCDs

Refusing to be followed up prospectively for routine visits

Status: Recruiting

Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment

Background: In 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. Objective: To understand how long-term congestion of blood in the liver causes liver scarring that eventually leads to cirrhosis. Eligibility: People aged 18 and older who are at risk of developing FALD from the Fontan procedure. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Liver ultrasound. This uses sound waves to take pictures of the body. Participants 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. Visits will include repeats of the screening tests and: Heart tests Stool collection Questionnaires MRI 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. Fibroscan exam. This is an ultrasound that uses a special probe to look at the toughness of the liver. Upper endoscopy. This uses a thin scope to look inside the upper digestive tract. Liver 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.

Participants needed: 100
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Updated: Jul 31, 2026Locations: 1
Eligibility criteria

Male and female subjects >= 18 years of age. [+5]

Evidence of other forms of liver disease that typically result in cirrhosis. [+13]

Status: Recruiting

Longitudinal Validation of CIRC Technologies

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. The 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.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: The Cleveland ClinicUpdated: Jul 31, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years of age [+1]

Vulnerable populations will be excluded from this study including Prisoners [+2]

Status: Recruiting

Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

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.

Participants needed: 174
Trial details
Age: Up to 50Biological sex: AllType: ObservationalSponsor: Institut National de la Santé Et de la Recherche Médicale, FranceUpdated: Jul 30, 2026Locations: 5
Eligibility criteria

Age at least 18 years old [+21]

Status: Recruiting

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

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.).

Participants needed: 20
Trial details
Biological sex: AllType: InterventionalSponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUpdated: Jul 28, 2026Locations: 1
Eligibility criteria

Infants admitted to the NICU with a gestational age of ≥ 32 weeks at the time of... [+1]

Infants with a skin abnormality that would potentially increase the risk of inju... [+1]

Status: Not yet recruiting

Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics

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. The 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.

Participants needed: 100
Trial details
Age: 0-21Biological sex: AllType: ObservationalSponsor: Boston Children's HospitalUpdated: Jul 27, 2026Locations: 1
Eligibility criteria

Age less than 21 years at the time of enrollment. [+2]

Presence of skin, scalp, or craniofacial abnormalities that prevent proper place... [+1]

Status: Not yet recruiting

Exercise Prehabilitation in Congenital Heart Disease

Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD). Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood. As 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. Participants 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. All 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. The results of each participant's routine CPET will be used to guide the individualised exercise programme in the intervention group. Exercise 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. Participants in the trial will complete an additional second CPET following the trial period. The 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.

Participants needed: 32
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Liverpool Heart and Chest Hospital NHS Foundation TrustUpdated: Jul 22, 2026
Eligibility criteria

Adults with congenital heart disease requiring cardiac surgery via sternotomy or... [+5]

Surgery is scheduled for a date that precludes participation in the programme -... [+9]

Status: Recruiting

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

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.

Participants needed: 600
Trial details
Age: 6-18Biological sex: AllType: InterventionalSponsor: Alexandra Miriam KiessUpdated: Jul 21, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

HFNC vs NIPPV Following Extubation

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. This 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. Both 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.

Participants needed: 200
Trial details
Age: Up to 1Biological sex: AllType: InterventionalSponsor: Emory UniversityUpdated: Jul 14, 2026Locations: 1
Eligibility criteria

All patients admitted to the CICU following cardiac surgery for CHD who are </=...

Patients who remain intubated for >/= 4 weeks [+6]

Status: Not yet recruiting

Interoceptive Intervention for Congenital Heart Disease

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. Interoceptive-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. Thirty-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/Waitlist 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. Participants 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. Findings 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.

Participants needed: 32
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of GlasgowUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Participants must be aged 18 years or older [+5]

Individuals with current suicidal ideation [+6]

Status: Recruiting

Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)

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/physical variables.

Participants needed: 192
Trial details
Age: 8-25Biological sex: AllType: InterventionalSponsor: University Hospital, BordeauxUpdated: Jul 8, 2026Locations: 6
Eligibility criteria

Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/AC... [+4]

Unstable and/or severe heart failure: severe heart failure (class IV NYHA functi... [+24]

Status: Recruiting

The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)

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. HF 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.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Universitätsklinikum Hamburg-EppendorfUpdated: Jul 1, 2026Locations: 1Duration: 30 Years
Eligibility criteria

The patient has to be listed as an adult transplant candidate in the country the... [+4]

Status: Not yet recruiting

Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective

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. The 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. This 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.

Participants needed: 20
Trial details
Age: 20-70Biological sex: AllType: ObservationalSponsor: The University of Hong KongUpdated: Jun 23, 2026Locations: 1
Eligibility criteria

Age 20 to 70 years old [+6]

Contraindication for undergoing physical exertion including cardio-pulmonary exe... [+2]

Status: Recruiting

Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

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.

Participants needed: 320
Trial details
Age: 0-21Biological sex: AllType: InterventionalSponsor: University of California, DavisUpdated: Jun 18, 2026Locations: 3
Eligibility criteria

Age < 22 days [+3]

Echocardiogram completed prior to enrollment as the newborn would then no longer... [+1]

Status: Not yet recruiting

Tailored MgSO4 Supplementation to Reduce Complications in Pediatric Heart Surgery

Lay Summary This 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. In 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. To 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.

Participants needed: 96
Trial details
Age: 0-18Biological sex: AllType: InterventionalSponsor: West Virginia UniversityUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Children undergoing cardiac surgery utilizing cardiopulmonary bypass

Children undergoing cardiac surgery without cardiopulmonary bypass [+3]

Status: Not yet recruiting

Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease

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. The main questions it aims to answer are: Does 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? All 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. Participants will: Wear 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. Complete a 2-week observation period after the program to see whether physical activity changes are maintained. Complete study assessments at screening, the end of baseline, week 4, week 8, week 12, and the end of the observation period. Researchers will also collect information on step counts, energy expenditure, self-reported physical activity, exercise capacity, quality of life, adherence, acceptability, and adverse events.

Participants needed: 13
Trial details
Age: 8-18Biological sex: AllType: InterventionalSponsor: The Children's Hospital of Zhejiang University School of MedicineUpdated: May 18, 2026Locations: 1
Eligibility criteria

aged 8-18 years, with a confirmed diagnosis of congenital heart disease and a hi... [+6]

clear contraindications to exercise, such as uncontrolled arrhythmia, overt hear... [+3]

Status: Recruiting

Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease

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.

Participants needed: 160
Trial details
Age: 0-6Biological sex: AllType: InterventionalSponsor: Children's Hospital of Fudan UniversityUpdated: May 13, 2026Locations: 1
Eligibility criteria

Diagnosed with congenital heart disease through symptoms, physical signs, imagin... [+5]

Diagnosed with major non cardiac diseases leading to nutritional intake disorder... [+4]

Status: Recruiting

PDA for Kidneys Study

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. Researchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.

Participants needed: 45
Trial details
Age: 1-7Biological sex: AllType: ObservationalSponsor: University of Wisconsin, MadisonUpdated: May 15, 2026Locations: 1
Eligibility criteria

Delivered at <32 weeks' gestation [+3]

Major congenital anomalies of kidney [+3]

Status: Not yet recruiting

Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach

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. The primary questions the study aims to answer are: Does the nursing program positively affect the physical growth of children, such as their height and weight? Does the program improve children's scores on general development tests (Denver II)? Do parents' attitudes toward child feeding and their confidence in parenting skills increase? Researchers will divide participants into two groups: Experimental Group: Families who participate in the nursing education program and receive an informative booklet. Control Group: Families who only receive an informative booklet and continue with routine hospital follow-ups. The 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. Participants will be asked to: Attend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up. Meet 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. Complete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.

Participants needed: 80
Trial details
Age: 1-3Biological sex: AllType: InterventionalSponsor: Cukurova UniversityUpdated: May 12, 2026Locations: 3
Eligibility criteria

Families who agree to participate in the study and sign the informed consent for... [+3]

Exclusion criteria include the presence of additional congenital malformations,...

Status: Recruiting

Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children

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: -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? Participants 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.

Participants needed: 330
Trial details
Age: 1-12Biological sex: AllType: ObservationalSponsor: Boston Children's HospitalUpdated: May 12, 2026Locations: 1
Eligibility criteria

Children < 12 years old [+2]

Premature infants (<37 weeks' gestation) [+2]

Status: Recruiting

Development of CIRC Technologies

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. Our 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.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: The Cleveland ClinicUpdated: May 8, 2026Locations: 1Duration: 20 Years
Eligibility criteria

Age ≥ 18 years of age [+2]

Vulnerable populations will be excluded from this study including Prisoners [+2]