Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart drug udenafil tested for long-term safety in teens with rare heart defect

NCT ID NCT03013751

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

301 people

The number who actually took part.

Started

Feb 2017

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females with Fontan physiology who participated in the FUEL trial or, if they did not participate in FUEL, those who are 12 to less than 19 years of age at enrollment. 2. Participant consent or parental/guardian consent and participant assent. 3. Participant fluent in English, Spanish, or Korean. 4. Current anti-platelet or anticoagulant therapy. Exclusion Criteria: 1. Height \< 132 cm. 2. Weight \< 40 kg. 3. Hospitalization for acute decompensated heart failure within the last 12 months. 4. Current intravenous inotropic drugs. 5. Undergoing evaluation for heart transplantation or listed for transplantation. 6. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last three years, or a history of liver cirrhosis. 7. Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \> 4 mm Hg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography. 8. Single lung physiology. 9. Maximal VO2 less than 50% of predicted for age and gender at enrollment. 10. Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment. 11. Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment. 12. Significant renal, hepatic, gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications. 13. Inability to complete exercise testing at baseline screening. 14. History of PDE-5 inhibitor use (with the exception of FUEL participation) within 3 months before study onset. 15. Use of any other drug to treat pulmonary hypertension within 3 months before study onset. 16. Known intolerance to oral udenafil. 17. Frequent use of medications or other substances that inhibit or induce CYP3A4. 18. Current use of alpha-blockers or nitrates. 19. Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results. 20. Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results. 21. Cardiac care, ongoing or planned, at a non-study center that would impede study completion. 22. For females: Pregnancy at the time of screening, pregnancy planned before study completion, or refusal to use an acceptable method of contraception for study duration. 23. Unable to abstain or limit intake of grapefruit juice during the duration of the trial. 24. Refusal to provide written informed consent/assent. 25. In the opinion of the primary care physician, the subject is likely to be non-compliant with the study protocol. 26. History of clinically significant thromboembolic event, as adjudicated by study Investigators.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Functional single ventricle heart disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Functional single ventricle heart disease

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cedars/Sinai Heart Institute

    Los Angeles, California, 90048, 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 New York

    New York, New York, 10032, 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 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

  • Johns Hopkins All Children's Heart Institute

    St. Petersburg, Florida, 33701, 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

  • Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

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

    Salt Lake City, Utah, 84113, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Riley Hospital for Children/Herman B. Wells Center for Pediatric Research

    Indianapolis, Indiana, 46201, United States

  • Seattle Children's Hosptial

    Seattle, Washington, 98105, United States

  • Sejong General Hospital

    Bucheon-si, Gyeonggi-do, 14754, South Korea

  • Seoul National University Children's Hospital

    Seoul, 110-744, South Korea

  • 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/C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109-4204, United States

  • Washington University St. Louis/St.Louis Children's Hospital

    St Louis, Missouri, 63110, United States