47 completed, 20 recruiting, 6 unknown, 5 withdrawn. 26 Not applicable, 11 Phase 2, 7 Phase 3, 5 Phase 1, 2 Phase 4.
Follow Univentricular Heart: new trials by email Literature Review of Univentricular Heart trials Research Report on Univentricular Heart
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS) | Recruiting | Metcela Inc. | 40 | 2026-09-01 | 2026-10-20 | |
| PRecision Integrated Saturation Monitor vital sign monitoring - CHD - Congenital Heart Disease, Single Ventricle Heart Disease | Recruiting | Le Bonheur Children's Hospital | 100 | 2026-08-01 | 2026-07-07 | |
| Venous Compression in Fontan Lower extremity compression garments, Without compression garments - Single-ventricle, Fontan Circulation | Not applicable | Recruiting | University of Texas Southwestern Medical Center | 20 | 2026-05-10 | 2026-07-30 |
| Occlutech AFR Fontan Study Occlutech Atrial Flow Regulator Retrospective Data Collection - Failure of Fontan Type Circulation, Fenestration | Not yet recruiting | Occlutech International AB | 25 | 2026-05-01 | 2026-04-15 | |
| Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity Cardiopulmonary Exercise Testing (CPET), Shear Wave Elastography Scan - Single-ventricle, Stenosis | Recruiting | Children's Hospital Los Angeles | 20 | 2025-08-01 | 2025-07-18 | |
| Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology Fortini formula, Standard Nutritional Care - Single-ventricle | Not applicable | Recruiting | Driscoll Children's Hospital | 100 | 2025-07-30 | 2026-05-13 |
| Fontan Fitness Trial Digital Exercise Intervention - Single-ventricle, Congenital Heart Disease | Not applicable | Recruiting | Children's Hospital of Philadelphia | 200 | 2025-06-09 | 2026-04-13 |
| Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD Fontan Procedure - Congenital Heart Disease (CHD), Univentricular Heart | Recruiting | Sisca Natalia Siagian | 52 | 2025-01-01 | 2026-04-17 | |
| Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis Collecting discarded blood samples - Congenital Heart Disease, Single-ventricle | Recruiting | Boston Children's Hospital | 10 | 2024-10-31 | 2026-02-23 | |
| PK/PD of Digoxin in Infants With SVHD PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease - Single-ventricle, Infant Conditions | Phase 1 / Phase 2 | Completed | Duke University | 24 | 2024-10-10 | 2026-08-14 |
| Association of Near Infrared Spectroscopy With Interstage Outcomes Near infrared spectroscopy - Single-ventricle | Not applicable | Unknown | Advocate Hospital System | 20 | 2024-07-01 | 2024-08-07 |
| REHAB Fontan Failure: A Trial of Cardiac Rehabilitation Cardiac rehabilitation, Usual care - Heart Failure Congenital, Single-ventricle | Not applicable | Recruiting | Stanford University | 50 | 2024-05-05 | 2026-01-05 |
| Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation Cardiac magnetic resonance stress-perfusion - Univentricular Heart, Microvascular Dysfunction | Recruiting | Karolinska Institutet | 30 | 2024-04-15 | 2024-12-16 | |
| Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan Hands-free oral-positive pressure device (oPEP) - Single-ventricle | Not applicable | Completed | Tarek Alsaied | 15 | 2023-08-01 | 2025-02-10 |
| Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease Sildenafil, Placebos - Single-ventricle, Pulmonary Hypertension | Phase 3 | Withdrawn | University Hospital, Montpellier | 2023-06-01 | 2023-05-15 | |
| Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study LUX-Dx™ - Univentricular Heart | Early Phase 1 | Completed | Boston Children's Hospital | 10 | 2023-03-15 | 2026-05-19 |
| Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease iPSC-CL - Univentricular Heart, Congenital Heart Disease | Phase 1 | Recruiting | HeartWorks, Inc. | 50 | 2023-02-03 | 2026-03-13 |
| Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients Univentricular Heart | Unknown | Children's Health Ireland | 30 | 2023-01-10 | 2022-12-21 | |
| Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry SGLT2 inhibitors - Adult Congenital Heart Disease, Congenital Heart Disease | Recruiting | Leiden University Medical Center | 400 | 2023-01-01 | 2026-02-13 | |
| Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training Exercise training - Univentricular Heart, Congenital Heart Disease | Not applicable | Completed | University of Sao Paulo | 20 | 2022-09-26 | 2023-07-28 |
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Heart Defects, Congenital (42) · Hypoplastic Left Heart Syndrome (16) · Heart Failure (7) · Heart Diseases (4) · Lymphatic Abnormalities (4) · Tetralogy of Fallot (4) · Transposition of Great Vessels (3) · Tricuspid Atresia (3) · Aortic Coarctation (2) · Cardiovascular Diseases (2) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (2) · Hypertension, Pulmonary (2) · Lymphedema (2) · Protein-Losing Enteropathies (2)
Cardiovascular Abnormalities (84) · Congenital Abnormalities (84) · Cardiovascular Diseases (83) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (83) · Heart Diseases (81) · Heart Defects, Congenital (43) · Hemic and Lymphatic Diseases (6) · Lymphatic Diseases (5) · Respiratory Tract Diseases (5) · Heart Valve Diseases (4) · Vascular Diseases (4) · Behavior (3) · Lung Diseases (3) · Digestive System Diseases (2) · Gastrointestinal Diseases (2)
Exercise (3) · Exercise Test (3) · Arginine Vasopressin (2) · Demography (2) · Saline Solution (2) · Arginine (1) · Blood Specimen Collection (1) · Blood Vessel Prosthesis (1) · Bloodless Medical and Surgical Procedures (1) · Body Composition (1) · Cardiac Catheterization (1) · Cardiac Rehabilitation (1) · Carvedilol (1) · Colchicine (1) · Digoxin (1)
Boston Children's Hospital (7) · Children's Hospital of Philadelphia (4) · Emory University (4) · University Hospital, Montpellier (4) · Children's Mercy Hospital Kansas City (3) · Stanford University (3) · University of Aarhus (3) · University of Michigan (3) · Duke University (2) · Hacettepe University (2) · Metcela Inc. (2) · Okayama University (2) · University of Erlangen-Nürnberg Medical School (2) · University of Sao Paulo (2) · University of Texas Southwestern Medical Center (2)
United States (55) · Canada (5) · France (4) · Germany (4) · Japan (4) · Brazil (3) · Denmark (3) · China (2) · Sweden (2) · Turkey (Türkiye) (2) · United Kingdom (2) · Australia (1) · Czechia (1) · Indonesia (1) · Ireland (1)
Fred Wu, MD (2) · Hidemasa Oh, M.D., Ph.D. (2) · Mark Fogel, MD (2) · Rahul Rathod, MD (2) · Sven Dittrich, Prof. (2) · William Mahle, MD (2) · Adam James, MD (1) · Aida LR Turquetto, PhD student (1) · Anastasia D. Egorova, MD PhD (1) · Andrew M Atz, MD (1) · Angel Cuadrado, MD (1) · Barbara EU Burkhardt, MD (1) · Benjamin Frank, MD (1)
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R01HL090615 (2), 2018 (1), 5UH3HL148693 (1), R01HD106588 (1), R01HL149139 (1), R33HL146775 (1), R61HL146775 (1), R61HL171110 (1), U01HL068270 (1)