NCT05206955PHASE3Recruiting

Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

Mayo Clinic

Start Date

9/16/2022

Completion Date

11/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Tadalafil

DRUG

Placebo

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Conditions

Fontan Palliation

Locations

Mayo Clinic

Rochester, Minnesota 55905

United States