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

Launched by MAYO CLINIC · Jan 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Tadalafil to see if it can help improve blood flow and overall organ function in adults who have had a specific heart surgery known as Fontan Palliation. The study is currently looking for participants aged 18 and older who have undergone this surgery and can participate in exercise using a special bike while lying down. Patients will need to be able to give their written consent to join the trial.

Participants in this study can expect to be involved in assessments that will help doctors understand how well Tadalafil works compared to a placebo (a substance with no active medication). They will also need to be undergoing a routine heart procedure called Cardiac Catheterization as part of their regular care. It’s important to note that individuals who are currently using certain heart medications, are pregnant or breastfeeding, or are unable to exercise will not be eligible to participate. This trial aims to gather more information that could lead to better treatment options for patients with Fontan physiology.

Gender

ALL

Eligibility 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.