4 completed, 3 recruiting. 3 Phase 3, 2 Not applicable, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 2, Recruiting 1 |
| Not applicable | 2 | Completed 2 |
| Phase 2 | 1 | Recruiting 1 |
Follow Single Ventricle Heart Disease: new trials by email Literature Review of Single Ventricle Heart Disease trials Research Report on Single Ventricle Heart Disease
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 |
|---|---|---|---|---|---|---|
| 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 | |
| CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation Dapagliflozin tablet, Placebo Tablet - Fontan Circulation, Single Ventricle Heart Disease | Phase 2 | Recruiting | Mayo Clinic | 27 | 2025-05-16 | 2026-05-06 |
| Fontan Udenafil Exercise Longitudinal Assessment Trial - 2 Udenafil, Placebo - Single Ventricle Heart Disease | Phase 3 | Recruiting | Mezzion Pharma Co. Ltd | 436 | 2023-10-30 | 2025-10-28 |
| WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program WE BEAT Group Wellness Education program - phase 1, HEART Club Home Exercise program - phase 2 - Fontan Physiology, Frailty | Not applicable | Completed | University of Michigan | 30 | 2022-03-30 | 2026-07-10 |
| Cognitive Intervention to Improve Working Memory Cognitive Computer Based Intervention - Single Ventricle Heart Disease | Not applicable | Completed | University of California, Los Angeles | 5 | 2021-06-10 | 2022-09-21 |
| Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness Udenafil - Single Ventricle Heart Disease | Phase 3 | Completed | Mezzion Pharma Co. Ltd | 88 | 2018-02-20 | 2025-10-14 |
| Fontan Udenafil Exercise Longitudinal Assessment Trial Udenafil, Placebo - Single Ventricle Heart Disease | Phase 3 | Completed | Mezzion Pharma Co. Ltd | 400 | 2016-07-22 | 2025-06-17 |
Frailty (1) · Heart Defects, Congenital (1) · Univentricular Heart (1)
Cardiovascular Abnormalities (1) · Cardiovascular Diseases (1) · Congenital Abnormalities (1) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Heart Diseases (1) · Pathologic Processes (1) · Pathological Conditions, Signs and Symptoms (1)
udenafil (3) · dapagliflozin (1)
Mezzion Pharma Co. Ltd (3) · Le Bonheur Children's Hospital (1) · Mayo Clinic (1) · University of California, Los Angeles (1) · University of Michigan (1)
United States (7) · Canada (2) · South Korea (2)
David J Goldberg, MD (1) · Jesse Hansen, MD (1) · Kurt R Schumacher, MD (1) · Luke Burchill, M.B.B.S., Ph.D. (1) · Nancy Pike, PhD (1) · Steve Paridon, MD (1) · WG Kim (1)
PMID 29910047, PMID 31736357, PMID 36378780
U01HL068270 (2)