[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-ventricular-diastolic-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-ventricular-diastolic-dysfunction":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100650944","importance-of-point-of-care-ultrasound-for-early-detection-of-valvular-and-cardiac-diseases-improve-100650944",false,"NCT07756398","Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)","IMPROVE","Inclusion Criteria:\n\nProvider (cluster) participants:\n\n* Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients\n* Patient panel comprising \\>50% adults aged 65 years or older\n* Sees patients in ambulatory clinic at least 1 day per week on average\n* Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel\n* Provides written informed consent\n\nPatient participants:\n\n* Adults aged 65 to 85 years, inclusive\n* Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic\n* Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram\n\nExclusion Criteria:\n\nProvider (cluster) participants:\n\n* Serving in a locum tenens or other temporary capacity\n* Unwilling or unable to nominate an AI-POCUS champion from the clinic\n\nPatient participants:\n\n* Echocardiogram performed within the past 5 years\n* At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram\n* History of surgical or transcatheter intervention for aortic or mitral valve disease\n* Self-reported structural heart disease\n* Significant frailty burden or comorbidities limiting life expectancy to\n\n  1 year or less\n* Unable to provide informed consent","ALL","65 Years","85 Years",{"count":20,"type":21},1088,"ESTIMATED","INTERVENTIONAL",[24],"NA","Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed.\n\nThis study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care.\n\nPrimary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.",[27,28,29,30],"Valvular Heart Disease Patients","Aortic Stenosis","Mitral Regurgitation","Left Ventricular Diastolic Dysfunction",[32,33,34,35,36,37,38,39,40,41,42,43,44],"Point-of-care ultrasound","POCUS","Artificial Intelligence","AI-guided imaging","Echocardiography","Screening","Early detection","Heart Failure","Older Adults","Geriatrics","Primary Care","Cluster randomized Trial","Implementation Science","NOT_YET_RECRUITING","2026-08-12",{"date":48,"type":49},"2026-08-17","ACTUAL",{"date":51,"type":21},"2026-08-01",{"date":53,"type":21},"2028-12-01",{"name":55,"class":56},"University of Texas Southwestern Medical Center","OTHER",2,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":16,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":91,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100420250","pediatric-hypertension-and-the-renin-angiotensin-system-phrase-100420250","NCT04752293","Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)","Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage","PHRASE","INCLUSION CRITERIA: HYPERTENSION COHORT\n\n* 7-18 years of age at time of enrollment\n* Confirmed new diagnosis of primary hypertension: no identifiable secondary cause, referred to hypertension or nephrology clinic\n\n  * Age \\\u003C13 years: BP ≥95th %ile or ≥130\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP ≥130\u002F80 mmHg\n* Participants and their caregivers must be willing and able to commit to completing the study assessments\n\nEXCLUSION CRITERIA: HYPERTENSION COHORT\n\n* \\\u003C7 years or \\>18 years of age at time of enrollment\n* BP confirmed as normal or in the elevated BP category based on ≥3 prior office BP measurements on separate days;\n\n  * Age \\\u003C13 years: BP \\\u003C95th %ile or \\\u003C130\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP \\\u003C130\u002F80 mmHg\n* A confirmed secondary cause of hypertension\n* Confounding medical condition (heart or kidney disease \\[except hypertension-associated heart changes on echocardiogram or albuminuria\\], vascular\u002Finflammatory disease, or diabetes)\n* Inability to complete study assessments\n* Non-English\u002FSpanish speakers\n* Current pregnancy\n* Ward of the State\n\nINCLUSION CRITERIA: CONTROL COHORT\n\n* 7-18 years of age at time of enrollment\n* Normal BP based on ≥3 prior office BP measurements on separate days;\n\n  * Age \\\u003C13 years: BP \\\u003C90th %ile or \\\u003C120\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP \\\u003C120\u002F80 mmHg\n* Participants and their caregivers must be willing and able to commit to completing the study assessments\n\nEXCLUSION CRITERIA: CONTROL COHORT\n\n* \\\u003C7 or \\>18 years of age at time of enrollment\n* Elevated BP or hypertension, based on ≥3 prior office BP measurements on separate days:\n\n  * Age \\\u003C13 years: BP ≥90th %ile or ≥120\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP ≥120\u002F80 mmHg\n* History of elevated BP or hypertension\n* Current use of BP-lowering medications\n* Confounding medical condition (heart or kidney disease, vascular\u002Finflammatory disease, or diabetes)\n* Inability to complete study assessments\n* Non-English\u002FSpanish speakers\n* Current pregnancy\n* Ward of the State",true,"7 Years","18 Years",{"count":70,"type":21},125,"OBSERVATIONAL","Studying the causal roles of components of the renin-angiotensin-aldosterone system (including angiotensin-(1-7) (Ang-(1-7)), angiotensin-converting enzyme 2 (ACE2), Ang II, and ACE), uric acid, and klotho in pediatric hypertension and related target organ injury, including in the heart, kidneys, vasculature, and brain. Recruiting children with a new hypertension diagnosis over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist and Atrium Health Levine Children's Hospital. Healthy control participants will be recruited from local general primary care practices. Collecting blood and urine samples to analyze components of the renin-angiotensin-aldosterone system (Ang-(1-7), ACE2, Ang II, ACE), uric acid, and klotho, and measuring blood pressure, heart structure and function, autonomic function, vascular function, and kidney function at baseline, year 1, and year 2. Objectives are to investigate phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury due to hypertension.",[74,75,76,77,30,78,79,80,81,82,83,84,85,86,87,88,89,90],"Hypertension","Left Ventricular Hypertrophy","Left Ventricular Dysfunction","Left Atrial Dilatation","Kidney Diseases","Kidney Injury","Kidney Dysfunction","Sodium Urine High","Blood Pressure Disorders","Uric Acid Retention","Angiotensin Hypertension","Autonomic Dysfunction","Autonomic Imbalance","Pediatric Kidney Disease","Pediatric Obesity","Proteinuria","Albuminuria",[92,93,74,94,95,75,90,96,97,98,99,100,101,102,103,104,105,106,107,108,30,79,109,110,88,111,112,113,114],"High Blood Pressure","Elevated Blood Pressure","Pediatric Hypertension","Target Organ Damage","Uric Acid","Klotho","Fibroblast Growth Factor 23","Renin-Angiotensin-Aldosterone System","Renin-Angiotensin System","Angiotensin-(1-7)","Angiotensin II","Angiotensin-Converting Enzyme 2","Angiotensin-Converting Enzyme","Causal Inference","Causal Mediation Analysis","Sensitivity Analysis","Predictive Analysis","Heart Rate Variability","Sodium","Lifecourse","Kidney Function","Ambulatory Blood Pressure Monitoring","Echocardiogram","RECRUITING","2025-12-04",{"date":118,"type":49},"2025-12-11",{"date":120,"type":49},"2021-05-19",{"date":122,"type":21},"2026-12",{"name":124,"class":56},"Wake Forest University Health Sciences",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":17,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":125},"100549277","carvedilol--simvastatin-vs-carvedilol-alone-for-cirrhosis-and-cirrhotic-cardiomyopathy-and-impact-on-hepatic-decompensation-and-survival-100549277","NCT06431919","Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival","Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial","CIRROSTAT","Inclusion Criteria:\n\n* Age range of 18-65 years\n* Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,\n* CCM (with EF\\>50%) on 2D echocardiography with TDI\n* Written informed consent.\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Serum Creatinine\\>2 mg\u002Fdl\n* Patient previously treated with statin (one month before the study)\n* Contraindications to statins\n* Advanced Cirrhosis (CTP score\\>9)\n* Coronary artery disease\n* Sick sinus syndrome\u002F Pacemaker, valvular heart disease\n* Cardiac rhythm disorder, Peripartum cardiomyopathy\n* Portopulmonary hypertension\u002F hepatopulmonary syndrome\n* Transjugular intrahepatic portosystemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Pregnancy or lactation\n* Patients with HIV or retroviral therapy\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males\n* Acute variceal bleeding in last 6 months.\n* Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)",{"count":135,"type":21},260,[24],"Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.\n\nRationale:\n\nCirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy.\n\nNovelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins.\n\nObjectives:\n\nThe primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol.\n\nMethods:\n\nThis is a double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group.\n\nExpected Outcome:\n\nThe investigators anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).",[139,140,141,30,142],"Decompensated Cirrhosis","Cirrhotic Cardiomyopathy","Cirrhosis, Liver","Acute Kidney Injury",[139,140,144,145],"Left ventricular diastolic dysfunction","Acute kidney injury","2025-06-05",{"date":148,"type":49},"2025-06-08",{"date":150,"type":21},"2025-06-10",{"date":152,"type":21},"2028-02",{"name":154,"class":56},"Post Graduate Institute of Medical Education and Research, Chandigarh"]