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Could a common ED drug help fontan hearts? new trial aims to find out

NCT ID NCT05206955

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether tadalafil, a drug that relaxes blood vessels, can improve blood flow and protect organs in adults who had Fontan surgery for a single-ventricle heart defect. About 80 participants will receive either tadalafil or a placebo daily for a year. Researchers will measure changes in blood vessel function, liver stiffness, kidney function, and exercise capacity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tadalafil
What this could lead to
If it works, this could lead to a new treatment to improve blood flow and protect the liver, kidneys, and exercise ability in people living with Fontan circulation.
What could go wrong
This is a phase 3 trial, but tadalafil has not been proven effective for this condition before. It may not improve outcomes, and side effects like headache or muscle aches are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fontan palliation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States