[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fontan\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fontan":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,98,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100630074","phase-4-the-effect-of-dapagliflozin-on-exercise-and-cardiac-functional-status-of-patients-after-fontan-procedure-100630074",false,"NCT07482943","The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure","Inclusion Criteria:\n\n* Patients with a functional single ventricle and who have undergone Fontan procedure\n* Adolescents aged ≥ 12 years with body weight ≥30kg and adults\n\nExclusion Criteria:\n\n* Planned cardiac and\u002For non-cardiac surgery in 3 months\n* Arrhythmias requiring change in therapy in recent 6 months\n* Intervention procedure within 6 months prior to enrollment\n* Documented structural abnormalities of the Fontan circulation\n* Chronic kidney disease stages 4 to 5\n* Inability to perform cardiopulmonary test\n* Recent use of SGLT2 inhibitors within 6 months\n* Known hypersensitivity to SGLT2 inhibitors\n* History of diabetic ketoacidosis\n* Recent symptomatic hypoglycaemia within 6 months\n* Insulin dependent diabetes mellitus\n* History of perineum infection\n* Recent urinary tract infection within 6 months\n* Recent genital infection within 6 months\n* Other known contraindications to SGLT2 inhibitor\n* Pregnancy or breast feeding","ALL","12 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","While the Fontan operation improves survival for patients with a functional single ventricle, complications like heart failure remain prevalent during follow-up, causing frequent hospitalizations and reduced quality of life. Currently, there are no evidence-based heart failure therapies or guidelines for patients with Fontan palliation. There is growing interest in using sodium-glucose cotransporter 2 inhibitors (SGLT2i) to optimize cardiac conditions in this group. SGLT2i's observed benefits relate to protective effects on cardiac energy metabolism, renal function, sympathetic activation, inflammation, oxidative stress, erythropoiesis, and vascular function. Therefore, SGLT2i may represent a new therapeutic agent to improve exercise capacity and ventricular function in patients with Fontan circulation.\n\nThis prospective, open-label, single-arm clinical trial investigates the FDA-approved drug dapagliflozin. An open-label design is utilized due to the relatively small cohort of patients with complex underlying hearts. The trial will be conducted at Hong Kong Children's Hospital (the sole pediatric cardiology center in Hong Kong) and Queen Mary Hospital (the largest tertiary referral center for adult congenital heart patients). The total study duration is 2 years.\n\nSubjects will participate for 3 months, receiving oral dapagliflozin 10mg once daily. The primary endpoint is VO2 max (maximum rate of oxygen consumption) during cardiopulmonary exercise testing at 3 months. Secondary assessments include questionnaires, history taking, physical examinations, 12-lead electrocardiogram, blood tests, echocardiography, bioelectrical impedance analysis, and urine pregnancy tests.\n\nIf the hypothesis holds true, clinical translation of this project will: i) Improve long-term outcomes and quality-of-life for Fontan patients, reducing the healthcare burden from repeated heart failure hospitalizations; ii) Revolutionize the management of Fontan-associated heart failure by introducing SGLT2i as a novel, evidence-based therapy locally and globally; iii) Pave the way for multicenter international trials evaluating SGLT2i in the Fontan population and broader congenital heart diseases.",[25,26,27,28,29],"Fontan","Heart Failure","Dapagliflozin","Cardiovascular Diseases","Sodium-GLucose coTransporter-2 Inhibitors",[31,32,33,34,35],"fontan","heart failure","dapagliflozin","Sodium-glucose cotransporter 2 (SGLT2) inhibitor","Congenital heart disease","NOT_YET_RECRUITING","2026-03-15",{"date":39,"type":40},"2026-03-19","ACTUAL",{"date":42,"type":19},"2026-04",{"date":44,"type":19},"2028-04",{"name":46,"class":47},"The University of Hong Kong","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":71,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100587722","adult-congenital-heart-disease-international-evaluation-of-the-effectiveness-of-sglt2i-registry-100587722","NCT06932081","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry","ACHIEVE-SGLT2i","Inclusion Criteria:\n\n* Congenital heart defect.\n* Age ≥ 18 years.\n* Initiated on treatment with an SGLT2i.\n\nExclusion Criteria:\n\n\\- No consent for data collection.","18 Years",{"count":59,"type":19},400,"1 Year","OBSERVATIONAL","This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.",[64,65,66,67,68,25,69,70],"Adult Congenital Heart Disease","Congenital Heart Disease","Systemic Right Ventricle","Transposition of the Great Arteries","Congenitally Corrected Transposition of the Great Arteries","Single Ventricle","Tetralogy of Fallot (TOF)",[72,73,74,75,76,77,78,32,79,80,81,82,83,25,84,85,86],"adult congenital heart disease","ACHD","congenital heart disease","CHD","sodium-glucose cotransporter 2 inhibitors","SGLT2i","SGLT2","HF","transposition of the great arteries","TGA","systemic right ventricle","sRV","single ventricle","tetralogy of fallot","ToF","RECRUITING","2026-02-11",{"date":90,"type":40},"2026-02-13",{"date":92,"type":40},"2023-01-01",{"date":94,"type":19},"2027-12-31",{"name":96,"class":47},"Leiden University Medical Center",11,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":15,"minAge":57,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":121},"100593645","cholate-clearance-in-fontan-and-heart-failure-100593645","NCT07009132","Cholate Clearance in Fontan and Heart Failure","Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)","Inclusion Criteria:\n\n* Fontan: Adult Fontan patients ≥ 18 years of age who have undergone right heart catheterization within the past 1 year.\n* RHF Controls: non-Fontan adults with two ventricle anatomy with systemic left ventricle, CVP estimate ≥ 8 mmHg and left ventricle (LV) function ≥ 50% by echocardiogram performed within the past 1 year. Can include those with congenital heart disease- repaired or unrepaired.\n* Normal Controls: non-Fontan adults with normal cardiac anatomy, normal biventricular function, \\\u003C moderate tricuspid regurgitation and CVP estimate \\\u003C 5 mmHg by echocardiogram performed within the past 1 year.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Unable to comprehend and\u002For give informed consent\n* Sensitivity to human serum albumin, or its preparations\n* Participants with extensive resection of large segments of the small intestine (short gut) or severe gastroparesis\n* Participants on non-selective beta blockers, angiotensin converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), ursodeoxycholic acid, cholic acid, or other bile acids who are unwilling or unable to delay taking their normal dose the morning of their dual cholate clearance testing.\n* Participants on dietary supplements, bile acid sequestrants, GLP-1 agonists, narcotics, and other medications affecting gastric emptying or intestinal absorption who are unwilling or unable to delay taking or withhold as outlined in the instructions on deviating from the SHUNT test.\n* Contraindication to cardiac MRI\n* For RHF and normal controls: diabetes, chronic liver disease, \\>moderate alcohol use, BMI \\>30, oxygen-dependent, pulmonary hypertension22 on therapy, known porto-pulmonary hypertension",true,{"count":107,"type":19},75,"The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease (FALD).\n\nThis study aims to understand the role impaired blood flow to the liver plays in liver function in Fontan patients compared to patients with right heart failure and healthy controls. The study will also determine whether cholate clearance is a good measure to use in this population, and whether it will be able to predict clinical outcomes.\n\nParticipants will undergo a HepQuant dual cholate clearance assay and a cardiac magnetic resonance imaging (MRI) at the beginning of the study, and then data on health status will be collected for 5 years.",[25,110],"Right Heart Failure","2025-09-09",{"date":113,"type":40},"2025-09-15",{"date":115,"type":40},"2025-08-04",{"date":117,"type":19},"2031-12",{"name":119,"class":120},"HepQuant, LLC","INDUSTRY",1,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":130,"enrollmentInfo":131,"targetDuration":133,"studyType":61,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":121},"100384660","canadian-adult-congenital-heart-disease-intervention-registry-100384660","NCT04288596","Canadian Adult Congenital Heart Disease Intervention Registry","The Canadian Registry for Adults With Congenital Heart Disease Interventions","C-ACHDiR","Inclusion Criteria:\n\n* participants must be 18 years or older referred for intervention for one of five ACHD conditions including diagnostic catheterization for complex ACHD patients (Tetralogy of Fallot, Fontan, and transposition of the great vessels, single ventricle, truncus arteriosus); transcatheter closure of atrial septal defects; transcatheter closure of patent foramen ovale; coarctation of aorta stenting, and percutaneous pulmonary valve implantation.\n\nExclusion Criteria:\n\n* participants below the age of 18\n* participants residing outside of Canada","110 Years",{"count":132,"type":19},9000,"10 Years","The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.",[136,137,138,25,139,140,141],"Atrial Septal Defect","Patent Foramen Ovale","Tetralogy of Fallot","Coarctation of Aorta","Transposition of Great Vessels","Percutaneous Pulmonary Valve Implantation","2020-02-27",{"date":144,"type":40},"2020-02-28",{"date":146,"type":19},"2020-04-01",{"date":148,"type":19},"2030-04-01",{"name":150,"class":47},"University Health Network, Toronto"]