Could a heart pill help fontan teens breathe easier during exercise?

NCT ID NCT05918211

Recruiting now Disease control Sponsor: Mezzion Pharma Co. Ltd Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug udenafil can improve exercise ability in adolescents aged 12-18 who have had the Fontan procedure for single ventricle heart disease. Participants will take udenafil or a placebo daily for 26 weeks, and their exercise capacity will be measured. The trial aims to enroll 436 people across multiple sites.

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 it works, this could lead to a new treatment to help teens with Fontan circulation exercise more easily and have better heart function.
What could go wrong: This is a Phase 3 trial, but udenafil may not improve exercise capacity more than placebo. Side effects from the drug are possible.

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.

univentricular cardiopathy

As listed by the trial registrant

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

SINGLE VENTRICLE HEART DISEASE

Contacts and locations

Locations

Arkansas Children's
RECRUITING

Little Rock, Arkansas, 72202, United States
Boston Children's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Children's Healthcare of Atlanta
RECRUITING

Atlanta, Georgia, 30329, United States
Children's Hospital of Colorado
RECRUITING

Denver, Colorado, 80045, United States
Children's Hospital of Georgia
RECRUITING

Augusta, Georgia, 30912, United States
Children's Hospital of Los Angeles
RECRUITING

Los Angeles, California, 90027, United States
Children's Hospital of Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Children's Mercy Hospital Kansas City
RECRUITING

Kansas City, Missouri, 64108, United States
Childrens National Medical Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Cincinnati Childrens Hospital Medical Center
RECRUITING

Cincinnati, Ohio, 45206, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
[email protected]
NOT_YET_RECRUITING

Charlotte, North Carolina, 28204, United States
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
Joe DiMaggio Children's Hospital
RECRUITING

Hollywood, Florida, 33021, United States
Johns Hopkins All Children's Hospital
RECRUITING

St. Petersburg, Florida, 33701, United States
Lurie Children's Hospital
RECRUITING

Chicago, Illinois, 60611, United States
MUSC Pediatric Research Group
RECRUITING

Charleston, South Carolina, 29425, United States
Mt. Sinai Children's Hospital
NOT_YET_RECRUITING

New York, New York, 10029, United States
Nationwide Children's Hospital
RECRUITING

Columbus, Ohio, 43215, United States
Nemours Children's Hospital
RECRUITING

Wilmington, Delaware, 19803, United States
New York-Presbyterian Children's Hospital
RECRUITING

New York, New York, 10032, United States
Phoenix Children's Hospital
RECRUITING

Phoenix, Arizona, 85016, United States
Primary Children's Medical Center
RECRUITING

Salt Lake City, Utah, 84113, United States
Rady Children's Hospital
RECRUITING

San Diego, California, 92123, United States
Seattle Children's Hospital
RECRUITING

Seattle, Washington, 98105, United States
Sejong General Hospital
RECRUITING

Bucheon-si, Gyeonggi-do, 14754, South Korea
Seoul National University Children's Hospital
RECRUITING

Seoul, 03080, South Korea
Texas Children's Hospital
RECRUITING

Houston, Texas, 77030, United States
UCSF Benioff Children's Hospital
RECRUITING

San Francisco, California, 94158, United States
UF Health Shands Hospital
RECRUITING

Gainesville, Florida, 32608, United States
UT Southwestern Medical Center
RECRUITING

Dallas, Texas, 75235, United States
University of Chicago
RECRUITING

Chicago, Illinois, 60637, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Nebraska Children's Hospital and Medical Center
RECRUITING

Omaha, Nebraska, 68114, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Washington University
RECRUITING

St Louis, Missouri, 63130, United States
Yale School of Medicine
RECRUITING

New Haven, Connecticut, 06510, United States
Yonsei Severance Hospital
RECRUITING

Seoul, 03722, South Korea

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