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 shows promise for liver health in kids with rare heart condition

NCT ID NCT03430583

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

88 people

The number who actually took part.

Started

Feb 2018

Finished

Sep 2020

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 years and older

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. Enrollment in on-going Phase 3 Open-Label Safety Study 2. Informed assent from subject, informed consent from parent/legal guardian as appropriate Exclusion Criteria: 1. Non-enrollment in the on-going Phase 3 Open-Label Study 2. Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study) 3. Other exclusionary criteria will match those used for the Open-Label Safety Study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for 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.

Single ventricle heart disease

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.