Heart drug udenafil tested for long-term safety in teens with rare heart defect
NCT ID NCT03013751
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the long-term safety of udenafil in 301 adolescents with single ventricle heart disease who had Fontan surgery. Participants took the drug for 52 weeks. The main goal was to track side effects, with secondary measures including exercise capacity and blood vessel function.
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, this could support the long-term use of udenafil to help manage heart function in adolescents with single ventricle heart disease.
- What could go wrong
- This is a safety extension study, not designed to prove effectiveness. The drug may not improve outcomes and could have side effects.
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
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Cedars/Sinai Heart Institute
Los Angeles, California, 90048, United States
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Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Children's Hospital of New York
New York, New York, 10032, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Children's Mercy Hospital Kansas City
Kansas City, Missouri, 64108, United States
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Children's National Medical Center
Washington D.C., District of Columbia, 20008, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Johns Hopkins All Children's Heart Institute
St. Petersburg, Florida, 33701, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Nemours Cardiac Center/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
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Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
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Primary Children's Medical Hospital/Dept. of Pediatric Cardiology
Salt Lake City, Utah, 84113, United States
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Rady Children's Hospital
San Diego, California, 92123, United States
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Riley Hospital for Children/Herman B. Wells Center for Pediatric Research
Indianapolis, Indiana, 46201, United States
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Seattle Children's Hosptial
Seattle, Washington, 98105, United States
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Sejong General Hospital
Bucheon-si, Gyeonggi-do, 14754, South Korea
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Seoul National University Children's Hospital
Seoul, 110-744, South Korea
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Texas Children's Hospital
Houston, Texas, 77030, United States
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The Hospital for Sick Children
Toronto, Ontario, ON M5G 1X8, Canada
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University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109-4204, United States
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Washington University St. Louis/St.Louis Children's Hospital
St Louis, Missouri, 63110, United States