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

NCT ID NCT05206955

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.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States