17 completed, 9 recruiting, 3 unknown, 2 terminated. 13 Not applicable, 6 Phase 2, 4 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 13 | Completed 5, Recruiting 5, Unknown 2, Withdrawn 1 |
| Phase 2 | 6 | Completed 4, Recruiting 1, Terminated 1 |
| Phase 3 | 4 | Completed 2, Terminated 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
Follow Single-ventricle: new trials by email Literature Review of Single-ventricle trials Research Report on Single-ventricle
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 | |
| Ventripoint Single Ventricle Study Transthoracic Echocardiogram or Cardiac MRI, Ventripoint Echocardiogram - Congenital Heart Disease, Single-ventricle | Not applicable | Recruiting | Duke University | 100 | 2022-07-08 | 2025-10-23 |
| Enhanced External Counterpulsation in Patients With Fontan Circulation EECP - Single-ventricle, Congenital Heart Disease | Not applicable | Completed | Boston Children's Hospital | 23 | 2022-03-31 | 2023-06-13 |
| Virtual Remote Physiological Monitoring Program of Children With Heart Disease Remote physiological monitoring - Pediatric ALL, Congenital Heart Disease | Not applicable | Completed | University of Alberta | 23 | 2022-02-08 | 2025-01-31 |
| Exercise Capacity in Patients With Fontan Procedure Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition - Single-ventricle, Fontan Procedure | Completed | Hacettepe University | 42 | 2021-09-20 | 2022-01-20 | |
| Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle Single-ventricle, Congenital Heart Disease | Completed | University Hospital, Montpellier | 33 | 2021-06-01 | 2023-10-27 | |
| The PaTHS Descriptive Correlational Longitudinal Study Single-ventricle, Posttraumatic Stress Disorder | Completed | Children's Mercy Hospital Kansas City | 22 | 2021-03-01 | 2022-07-22 | |
| Fibrosis and the Fontan Spironolactone - Single-ventricle | Phase 1 / Phase 2 | Completed | Children's Hospital of Philadelphia | 98 | 2021-02-11 | 2026-07-01 |
| Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function - Single-ventricle, Fontan Procedure | Completed | Hacettepe University | 61 | 2021-01-20 | 2024-03-21 | |
| Re-Energize Fontan Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention - Single-ventricle | Not applicable | Completed | Stanford University | 150 | 2020-08-06 | 2026-06-22 |
| Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts Tissue Engineered Vascular Grafts - HLH - Hypoplastic Left Heart Syndrome, DORV | Phase 2 | Recruiting | Nationwide Children's Hospital | 24 | 2020-07-15 | 2025-06-27 |
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Univentricular Heart (34) · Heart Defects, Congenital (15) · Heart Diseases (2) · Hypoplastic Left Heart Syndrome (2) · Tricuspid Atresia (2) · Aortic Coarctation (1) · Cardiovascular Abnormalities (1) · Cardiovascular Diseases (1) · Constriction, Pathologic (1) · Endocardial Cushion Defects (1) · Heart Failure (1) · Hypertension, Pulmonary (1) · Infant, Newborn, Diseases (1) · Infant, Premature, Diseases (1) · Pleural Effusion (1)
Congenital Abnormalities (34) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (34) · Cardiovascular Abnormalities (33) · Cardiovascular Diseases (33) · Heart Diseases (32) · Heart Defects, Congenital (19) · Heart Valve Diseases (2) · Respiratory Tract Diseases (2) · Vascular Diseases (2) · Digestive System Diseases (1) · Embolism and Thrombosis (1) · Gastrointestinal Diseases (1) · Heart Septal Defects (1) · Hematologic Diseases (1) · Hemic and Lymphatic Diseases (1)
Arginine Vasopressin (2) · Demography (2) · Exercise Test (2) · Saline Solution (2) · Arginine (1) · Blood Specimen Collection (1) · Blood Vessel Prosthesis (1) · Body Composition (1) · Cardiac Rehabilitation (1) · Colchicine (1) · Digoxin (1) · Echocardiography (1) · Exercise (1) · Hand Strength (1) · Hematocrit (1)
Boston Children's Hospital (5) · Children's Hospital of Philadelphia (2) · Duke University (2) · Hacettepe University (2) · Stanford University (2) · University Hospital, Montpellier (2) · University of Michigan (2) · Advocate Hospital System (1) · Barbara Burkhardt (1) · Children's Hospital Los Angeles (1) · Children's Mercy Hospital Kansas City (1) · Driscoll Children's Hospital (1) · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (1) · Maria Bano (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1)
United States (26) · Canada (2) · Turkey (Türkiye) (2) · France (1) · Switzerland (1)
Rahul Rathod, MD (2) · Barbara EU Burkhardt, MD (1) · Benjamin Frank, MD (1) · Carlos M Mery, MD, MPH (1) · Christoph Hornik, MD (1) · Christopher Breuer, MD (1) · Daniel E Clark, MD, MPH (1) · Elizabeth Goldmuntz, MD (1) · Fred Wu, MD (1) · Gabriel Altit (1) · George Hoffman, MD (1) · Jamie Penk, MD (1) · Jennifer Conway, MD (1) · Jonathan N Menachem, MD (1) · Joshua Meisner, MD, PhD (1)
PMID 33045409, PMID 34253175, PMID 36796574, PMID 36802928, PMID 36924606, PMID 37664999, PMID 39470752, PMID 39625244, PMID 40456431, PMID 42422410
5UH3HL148693 (1), R01HD106588 (1), R01HL149139 (1), R33HL146775 (1), R61HL146775 (1), R61HL171110 (1)