Could a heart pill help fontan teens breathe easier during exercise?
NCT ID NCT05918211
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.
Disclaimer
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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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
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Study contacts
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Contact
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Arkansas Children's
RECRUITINGLittle Rock, Arkansas, 72202, United States
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Children's Healthcare of Atlanta
RECRUITINGAtlanta, Georgia, 30329, United States
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Children's Hospital of Colorado
RECRUITINGDenver, Colorado, 80045, United States
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Children's Hospital of Georgia
RECRUITINGAugusta, Georgia, 30912, United States
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Children's Hospital of Los Angeles
RECRUITINGLos Angeles, California, 90027, United States
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's Hospital of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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Children's Hospital of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Children's Mercy Hospital Kansas City
RECRUITINGKansas City, Missouri, 64108, United States
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Childrens National Medical Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Cincinnati Childrens Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45206, United States
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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NOT_YET_RECRUITING
Charlotte, North Carolina, 28204, United States
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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Joe DiMaggio Children's Hospital
RECRUITINGHollywood, Florida, 33021, United States
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Johns Hopkins All Children's Hospital
RECRUITINGSt. Petersburg, Florida, 33701, United States
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Lurie Children's Hospital
RECRUITINGChicago, Illinois, 60611, United States
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MUSC Pediatric Research Group
RECRUITINGCharleston, South Carolina, 29425, United States
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Mt. Sinai Children's Hospital
NOT_YET_RECRUITINGNew York, New York, 10029, United States
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43215, United States
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Nemours Children's Hospital
RECRUITINGWilmington, Delaware, 19803, United States
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New York-Presbyterian Children's Hospital
RECRUITINGNew York, New York, 10032, United States
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Phoenix Children's Hospital
RECRUITINGPhoenix, Arizona, 85016, United States
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Primary Children's Medical Center
RECRUITINGSalt Lake City, Utah, 84113, United States
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Rady Children's Hospital
RECRUITINGSan Diego, California, 92123, United States
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Seattle Children's Hospital
RECRUITINGSeattle, Washington, 98105, United States
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Sejong General Hospital
RECRUITINGBucheon-si, Gyeonggi-do, 14754, South Korea
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Seoul National University Children's Hospital
RECRUITINGSeoul, 03080, South Korea
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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
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UCSF Benioff Children's Hospital
RECRUITINGSan Francisco, California, 94158, United States
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UF Health Shands Hospital
RECRUITINGGainesville, Florida, 32608, United States
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75235, United States
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University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Nebraska Children's Hospital and Medical Center
RECRUITINGOmaha, Nebraska, 68114, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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Washington University
RECRUITINGSt Louis, Missouri, 63130, United States
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Yale School of Medicine
RECRUITINGNew Haven, Connecticut, 06510, United States
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Yonsei Severance Hospital
RECRUITINGSeoul, 03722, South Korea
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