RecruitingPhase 3

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

United States80 participantsStarted 2022-09-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Microvascular endothelial function

Timeframe: 52 weeks

Pulmonary vascular reserve

Timeframe: 52 weeks

Trial details

NCT IDNCT05206955

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

ACHD Research Team

507-293-2565 RSTACHDRESPRG@mayo.edu

View on ClinicalTrials.gov More Fontan Palliation trials