[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fontan-circulation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fontan-circulation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,78,107,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100574721","phase-2-cameo-fontan--dapagliflozin-in-the-failing-fontan-circulation-100574721",false,"NCT06762964","CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation","Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study","Inclusion Criteria\n\n1. Signed informed consent prior to any study specific procedures\n2. History of Fontan procedure\n3. Male or female subject\n4. Age ≥ 18\n5. Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation\n6. Elevated peripheral venous pressure (PVP) at rest or during exercise (≥20 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.\n\nExclusion Criteria\n\n1. Type I diabetes\n2. Any of the following medications: Insulin or Pramlintide, Sandostatin, Akeega (abiraterone acetate), Growth Hormone (Somatogrogon-GHLA), Lithium, Chloroquine, Hydroxychloroquine, Thioctic acid (alpha lipoic acid), Empagliflozin or Canagliflozin\n3. Recent hospitalization (\\\u003C30 days) or revascularization (\\\u003C90 days)\n4. Significant valvular heart disease (≥moderate stenosis, \\>moderate regurgitation)\n5. Significant Fontan obstruction with resting SVC-IVC gradient \\>4 mmHg\n6. Primary cardiomyopathy (such as amyloid)\n7. Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator\n8. Severe anemia (hemoglobin \\\u003C9 gm\u002Fdl)\n9. Severe kidney disease (estimated GFR\\\u003C30) or liver disease\n10. Women of childbearing potential not willing to use a medically accepted method of contraception OR who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n11. History of serious hypersensitivity reaction to dapagliflozin\n12. Subjects on dialysis\n13. Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding\n14. Single ventricle heart disease without Fontan palliation\n15. Those with a history of Fontan takedown","ALL","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.",[26,27,28],"Fontan Circulation","Single Ventricle Heart Disease","HFpEF - Heart Failure With Preserved Ejection Fraction",[30,31,32],"Fontan","HFpEF","SGLT2 inhibitors","RECRUITING","2026-05-05",{"date":36,"type":37},"2026-05-06","ACTUAL",{"date":39,"type":37},"2025-05-16",{"date":41,"type":20},"2027-02",{"name":43,"class":44},"Mayo Clinic","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100609872","venous-compression-in-fontan-100609872","NCT07220226","Venous Compression in Fontan","Venous Function and the Effect of Venous Compression on Exercise Cardiovascular Function in Patients With Fontan Circulation.","Patients with a Fontan circulation -\n\nInclusion criteria:\n\n• Patients at UTSW aged 18-45 years old with a Fontan circulation.\n\nExclusion Criteria:\n\n* NYHA Class 4\n* Severe AV valve regurgitation\n* Severe ventricular dysfunction\n* Large ascites\n* Significant varicosities\n* Atrio-pulmonary (AP) Fontan\n* Known Fontan thrombus\n* Poorly controlled arrythmia\n* Unplanned cardiac admission in the last 6 months\n* Cyanosis (resting O2 saturation \\\u003C85%)\n* Pregnant\n* Common femoral vein obstruction \\>50% to be performed following completion of informed consent.\n\nHealthy Controls:\n\nHealthy control participants will be recruited on the basis of having no known chronic diseases and not currently taking any cardiovascular medications.",true,"45 Years",{"count":56,"type":20},20,[58],"NA","The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses:\n\n1. Acute and chronic external venous compression will increase exercise stroke volume in patients with Fontan circulation.\n2. Patients with significant venous varicosities will have a greater response to venous compression.\n\nParticipants will:\n\n* Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments\n* Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments\n* A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours.\n\nParticipants will:\n\n* Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments\n* Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments\n* A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours.",[61,26],"Single-ventricle",[63,64,65,26,66,67],"Venous Compression","Exercise Testing","Cardiac Reserve","Magnetic Resonance Imaging","vascular function","NOT_YET_RECRUITING","2026-04-18",{"date":71,"type":37},"2026-04-22",{"date":73,"type":20},"2026-05-10",{"date":75,"type":20},"2027-11-01",{"name":77,"class":44},"University of Texas Southwestern Medical Center",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100625286","muscle-function-in-patients-with-single-chamber-heart-100625286","NCT07420660","Muscle Function in Patients With Single-chamber Heart","Importance of Muscle Function for Patients With Single-chamber Heart","Muscle in TCPC","Inclusion Criteria:\n\n* Diagnosis of a Fontan circulation: individuals who have undergone the Fontan procedure with only one functioning systemic ventricle, confirmed by medical records or attending physician.\n* Stable clinical status: patients should be clinically stable without significant cardiovascular or renal dysfunction as determined by clinical examinations.\n* Age range: 16-50 years.\n* Ability to exercise: Participants must be physically able to participate in the exercise protocol according to a preliminary medical examination.\n\nControls: Age and sex-matched. Healthy (no chronic diseases, assessed by health questionnaire and interview).\n\nExclusion Criteria:\n\n* Recent surgery or hospitalization: individuals who have undergone cardiovascular surgery or hospitalization within six months prior to inclusion.\n* Severe functional limitations: Patients with clear functional limitations unrelated to Fontan physiology, such as musculoskeletal disorders.\n* Significant comorbidities: Serious non-cardiac comorbidities that may independently affect work capacity, such as advanced pulmonary disease.\n* Contraindications for exercise testing: Conditions that contraindicate physical testing, such as uncontrolled cardiac arrhythmias or severe heart failure (New York Heart Association III-IV).","16 Years","50 Years",{"count":89,"type":20},40,"OBSERVATIONAL","Groundbreaking cardiac surgery has significantly improved survival rates for patients with single-chamber hearts. However, despite these life-saving interventions, the long-term prognosis remains concerning, with an increased risk of heart failure, sudden cardiac death, and reduced quality of life. The absence of a chamber that pumps blood to the lungs means individuals must rely on their leg muscles to passively return blood and oxygenate the lungs. Unfortunately, studies indicate reduced muscle mass and function in these patients.\n\nThe aim is to clarify the complex interplay between single-chamber circulation and muscle function, paving the way for targeted interventions such as muscle strengthening training for this unique patient group. Our hypothesis is that muscle mass and function correlate with circulatory limitations, and that muscle strengthening training could, over time, improve both muscle and circulatory function simultaneously.\n\nThe first part of the project includes tests for maximal oxygen uptake, heart and circulatory function, muscle strength, muscle mass\u002Fbody composition, and quality of life in adult patients (aged 16 and over) with single-chamber hearts.\n\nThe study may ultimately lead to improved interventions and exercise recommendations that promote an active lifestyle and enhance health, circulation, and physical function in patients with single-chamber hearts.",[26],[94,95,96,97],"Skeletal muscle","Fontan patients","Congenital heart disease","muscle function","2026-02-11",{"date":100,"type":37},"2026-02-19",{"date":102,"type":20},"2026-02-18",{"date":104,"type":20},"2026-05-31",{"name":106,"class":44},"Karolinska Institutet",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":114,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":45},"100541018","phase-1-improving-drug-dosing-and-outcomes-for-single-ventricle-patients-with-fontan-associated-liver-disease-100541018","NCT06324396","IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease","IMPROVE-FALD","Inclusion Criteria:\n\n* \\> 8 years\n* Status Post Fontan Completion\n* Ability to provide informed permission-assent (\\\u003C18 years) or consent (≥18 years)\n* Fasting overnight (\\~8 hours)\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-fasting\n* Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe\n* Sildenafil and\u002For Pravastatin therapy within last 2 months\n* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)\n* Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4\u002F5) inducers\u002Finhibitors) and\u002For Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers\u002Finhibitors)\n* Inability to swallow a tablet\n* \\>5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin\n* Diarrhea in the last 24 hours \\*History of solid organ transplantation","8 Years",{"count":116,"type":20},15,[118],"PHASE1","This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.",[26],[30,122],"FALD","2025-12-31",{"date":125,"type":37},"2026-01-02",{"date":127,"type":37},"2024-03-01",{"date":129,"type":20},"2026-12-31",{"name":131,"class":44},"Children's Mercy Hospital Kansas City",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":116},"100535942","fontan-circulation-and-reproductive-health-in-a-national-swedish-cohort-100535942","NCT06258382","Fontan Circulation and Reproductive Health in a National Swedish Cohort","Inclusion Criteria:\n\n* Fontan circulation,\n* Age ≥18 years at inclusion,\n* Follow-up at specialist clinics,\n* Ability to fill in questionnaires in the Swedish language (no other alternative available) or\n* Partner of a person with Fontan circulation,\n* Age ≥18 years at inclusion\n* Ability to fill in questionnaires in the Swedish language (no other alternative available).\n\nor •Age- and gender-matched individuals are recruited via the population registry. They must not have congenital heart disease.\n\nExclusion criteria: N\u002FA\n\n\\-",{"count":139,"type":20},600,"In the Swedish registry for congenital heart defects, SWEDCON, over 230 patients with single-ventricle circulation are registered in the adult section.\n\nCongenital heart defects affect career choices, family planning, and leisure activities. Questions regarding heredity and pregnancy are common.\n\nThe impact of Fontan circulation on reproductive health and fertility needs to be illuminated, and additional studies are required from both medical and psychosocial perspectives.Cognitive impairment is common among patients with congenital heart defects but is likely an overlooked cause of long-term illness.\n\nObjective To study a large national population (n=200) of adults with Fontan circulation and their potential partners regarding.\n\n* the prevalence and explanatory factors for sexual dysfunction and infertility in women and men with Fontan circulation (Study A).\n* the outcomes of pregnancy, choice of delivery mode, and complications in patients with Fontan circulation (Study B).\n* the experiences and perceptions of becoming parents among women (n=20) and men (n=20), as well as elucidate reasoning and family planning among women and men (n=20) who have not become parents (Study C).\n* Investigate the prevalence and explanatory factors for (Sub-study D):\n* Fatigue\n* In-depth cognitive screening to describe specific cognitive functions such as auditory memory, visuospatial memory, attention, cognitive speed, and executive functions.\n\nThe aim of this research is to gain more knowledge in an area that has been relatively underexplored, thus improving care for women and men with congenital heart defects.",[26],[143,144,145],"reproductive health","cognitive impairment","grown up heart disease","2024-10-11",{"date":148,"type":37},"2024-10-16",{"date":150,"type":37},"2023-11-01",{"date":152,"type":20},"2026-10-01",{"name":154,"class":155},"Caroline Lilliecreutz","OTHER_GOV"]