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Tadalafil for Improving Heart and Organ Function in Fontan Patients

This study is looking into whether Tadalafil can improve how well your heart and other organs work if you've had a Fontan Palliation (a type of heart surgery). Researchers want to see if Tadalafil helps with blood flow and how your body's tiny blood vessels function. You might be able to join if you are at least 18 years old, have had a Fontan Palliation, can exercise on a special bike, and are having a heart catheterization. The study will measure improvements in blood vessel function and lung blood vessel health after 52 weeks. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 80 participants. It compares Tadalafil to a placebo (an inactive substance that looks like the study drug).
What's involved
You would take Tadalafil or placebo orally once daily for 52 weeks, with the dose increasing over the first three weeks. You would also need to be able to exercise using a supine bike and undergo a cardiac catheterization.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for the study will be taken at 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05206955

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Mayo Clinic
~42 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:TadalafilPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Microvascular endothelial function
Measured over 52 weeks
+1 more outcome measured

Conditions

Fontan Palliation

Explore related trials

Fontan Procedure

NCT05206955

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alexander C Egbe, MBBS, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

ACHD Research Team
[email protected]
507-293-2565
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Microvascular endothelial function52 weeks

    Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)

  • Pulmonary vascular reserve52 weeks

    The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)