Comparing Tadalafil to Placebo for Patients with 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)
This study tests if Tadalafil can improve heart and organ function in adults who have had Fontan surgery compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05206955 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Tadalafil in enhancing hemodynamic capabilities and improving organ function in adults who have undergone Fontan Palliation. Participants will be randomly assigned to receive either Tadalafil or a placebo while undergoing clinically indicated cardiac catheterization. The study aims to assess the drug's impact on endothelial function and overall cardiovascular health in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have previously undergone Fontan Palliation and are capable of exercising on a supine bike.
Not a fit: Patients under 18 years old or those currently on specific medications like intravenous inotropes or pulmonary vasodilators may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with Fontan physiology, enhancing their quality of life and cardiovascular health.
How similar studies have performed: Other studies have explored similar interventions in cardiovascular conditions, but the specific application of Tadalafil in Fontan physiology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years old. * Have previously undergone a Fontan Palliation. * Able to exercise using a supine bike. * Ability and willingness to provide written consent. * Undergoing a clinically indicated Cardiac Catheterization Exclusion Criteria: * Patients \< 18 years old. * Current intravenous inotropic drugs. * Current use of alpha-blockers, pulmonary vasodilators, or nitrates. * Unable to exercise. * Pregnancy or lactating. * Unable or unwilling to consent.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Alexander C Egbe, MBBS, MPH — Mayo Clinic
- Study coordinator: ACHD Research Team
- Email: RSTACHDRESPRG@mayo.edu
- Phone: 507-293-2565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.