Heart drug shows promise for liver health in kids with rare heart condition

NCT ID NCT03430583

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the drug udenafil can reduce liver stiffness in 88 children with single ventricle heart disease, a condition where the heart has only one pumping chamber. Participants took udenafil twice daily for 52 weeks, and liver stiffness was measured using ultrasound and MRI. The goal was to see if the drug could help prevent liver damage, a common long-term complication in these children.

What this could mean

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

Active substance
Udenafil
What this could lead to
If successful, udenafil could help reduce liver stiffness in children with single ventricle heart disease, potentially lowering the risk of liver damage over time.
What could go wrong
This is a small, completed phase 3 study with only 88 participants. Results may not apply to all patients, and udenafil may cause side effects like headache or flushing. The drug is not a cure and does not replace standard heart care.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Children's Mercy Hospital

    Kansas City, Kansas, 64108, United States

  • Children's Mercy Hospital Kansas City

    Kansas City, Missouri, 64108, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20008, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Nemours Cardiac Center/Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Primary Children's Medical Hospital/Dept. of Pediatric Cardiology

    Salt Lake City, Utah, 84113, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Hospital for Sick Children

    Toronto, Ontario, ON M5G 1X8, Canada

  • University of Michigan Congenital Heart Center

    Ann Arbor, Michigan, 48109-4204, United States

  • University of Nebraska Children's Hospital and Medical Center

    Omaha, Nebraska, 68114, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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