Trials / Recruiting
RecruitingNCT05206955
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tadalafil | 10 mg once daily orally week 1, 20 mg once daily orally during week 2, and 40 mg once daily orally during weeks 3 through 52 |
| DRUG | Placebo | Looks exactly like the study drug, but it contains no active ingredient |
Timeline
- Start date
- 2022-09-16
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2022-01-25
- Last updated
- 2025-11-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05206955. Inclusion in this directory is not an endorsement.