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RecruitingPhase 3

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Mezzion Pharma Co. Ltd · NCT05918211

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–18 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
436
US sites recruiting
35
Study start
October 30, 2023
Record last updated
October 28, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

Being studied: Udenafil; Placebo

Conditions: Single Ventricle Heart Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment.
  • Participant consent or parental/guardian consent and participant assent.
  • Participant fluency in primary language of country in which study is being conducted.
  • Current antiplatelet or anticoagulant therapy.

Exclusion Criteria

  • Height \< 132 cm.
  • Weight \< 40 kg.
  • Hospitalization for acute decompensated heart failure within the last 12 months.
  • Current intravenous inotropic drugs.
  • Undergoing evaluation for heart transplantation or listed for transplantation.
  • Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.
  • Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of > 4 mmHg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography, obtained prior to screening for the trial.
  • Single lung physiology with greater than 80% flow to one lung.
  • Failure to achieve maximal exertion (defined as RER \< 1.10) on screening/baseline exercise test.
  • Peak minute oxygen consumption (VO2) less than 45% or ≥ 80% of predicated for age and gender at enrollment.
  • Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within 6 months prior to enrollment.
  • Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
  • History of significant renal (serum creatinine > 2.0), hepatic (serum AST and/or ALT > 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications.
  • Inability to complete exercise testing at baseline screening.
  • Subjects with a pacemaker whose heart rate at peak exercise is controlled by the extrinsic pacemaker as opposed to a native atrial rhythm.
  • History of PDE-5 inhibitor use within 12 months prior to enrollment. (Treatment is defined as chronic therapy as opposed to a single dose.)
  • History of any other medication for treatment of pulmonary hypertension within 3 months before study onset.
  • Known intolerance to oral udenafil.
  • Frequent use of medications or other substances that inhibit or induce CYP3A4.
  • Current use of alpha-blockers or nitrates.
  • Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.
  • Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
  • Cardiac care, ongoing or planned, at a non-study center that would impede study completion.
  • 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 if sexually active.
  • Unable to abstain or limit intake of grapefruit juice and grapefruit containing drinks during the duration of the trial.
  • Refusal to provide written informed consent/assent.
  • In the opinion of the investigator, the subject is likely to be non-compliant with the study protocol.
  • History of clinically significant thromboembolic event, in the option of the site Principal Investigator, that may put the subject at increased risk of a subsequent event while participating in the study.
  • Coronavirus disease 2019 (COVID-19) vaccination or symptoms of COVID-19 infection within 7 days of Visit 1.
  • Not taking antiplatelet or anticoagulant therapy.

Recruiting US locations

  • Phoenix Children's Hospital

    Phoenix, AZ 85016

    Site contact: Jade Porche · 602-933-6835 · jporche@phoenixchildrens.com

  • Arkansas Children's

    Little Rock, AR 72202

    Site contact: Wendy Haley · 501-364-2237 · haleyw@archildren's.org

  • Children's Hospital of Los Angeles

    Los Angeles, CA 90027

    Site contact: Matthew Dam · 323-361-7881 · mdam@chla.usc.edu

  • Rady Children's Hospital

    San Diego, CA 92123

    Site contact: Mark Abcede · 619-987-0650 · mabcede1@rchsd.org

  • UCSF Benioff Children's Hospital

    San Francisco, CA 94158

    Site contact: Aisling Conneally · 510-600-2965 · aisling.conneally@ucsf.edu

  • Children's Hospital of Colorado

    Denver, CO 80045

    Site contact: Andrea DeMarsh · 216-906-7931 · andrea.demarsh@childrenscolorado.org

  • Yale School of Medicine

    New Haven, CT 06510

    Site contact: Amanda Catucci · 631-897-6722 · amanda.catucci@yale.edu

  • Nemours Children's Hospital

    Wilmington, DE 19803

    Site contact: Carol Prospero · 302-651-6686 · carol.prospero@nemours.org

  • Childrens National Medical Center

    Washington D.C., DC 20010

    Site contact: Stacy Davenport · 240-547-9804 · amatthews@childrensnational.org

  • UF Health Shands Hospital

    Gainesville, FL 32608

    Site contact: Dalia Lopez-Colon · 352-281-6723 · dalylc@ufl.edu

  • Joe DiMaggio Children's Hospital

    Hollywood, FL 33021

    Site contact: Norma Barton · 954-265-4466 · NBarton@mhs.net

  • Johns Hopkins All Children's Hospital

    St. Petersburg, FL 33701

    Site contact: Lexie Dallas · 727-767-2465 · adallas@jhmi.edu

  • Children's Healthcare of Atlanta

    Atlanta, GA 30329

    Site contact: Jessica Braun · 404-785-3828 · jessica.braun@choa.org

  • Children's Hospital of Georgia

    Augusta, GA 30912

    Site contact: Michelle Collins · 706-721-9680 · MCOLLINS2@augusta.edu

  • Lurie Children's Hospital

    Chicago, IL 60611

    Site contact: Jessica Bhavsar · 312-227-4432 · jbhavsar@luriechildrens.org

  • University of Chicago

    Chicago, IL 60637

    Site contact: Becky Puplava · 773-702-2879 · rpuplava@bsd.uchicago.edu

  • Boston Children's Hospital

    Boston, MA 02115

    Site contact: Tom Giorgio · 617-355-4201 · thomas.giorgio@cardio.chboston.org

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Cynthia Smith · 734-615-0590 · csmithw@med.umich.edu

  • Children's Mercy Hospital Kansas City

    Kansas City, MO 64108

    Site contact: Dara Watkins · 816-302-3633 · djwatkins@cmh.org

  • Washington University

    St Louis, MO 63130

    Site contact: Mason Basler · 618-579-5674 · basler@wustl.edu

  • University of Nebraska Children's Hospital and Medical Center

    Omaha, NE 68114

    Site contact: Morgan Loeffelbein · 402-559-0681 · mloeffelbein@unmc.edu

  • New York-Presbyterian Children's Hospital

    New York, NY 10032

    Site contact: Katrina Golub · 212-342-1562 · kg2697@cumc.columbia.edu

  • Duke University Medical Center

    Durham, NC 27710

    Site contact: Alexi Pifer · alexis.pifer@duke.edu

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, OH 45206

    Site contact: Mariah Palmer · 513-636-9516 · Mariah.Palmer@cchmc.org

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Ewing Paige · 216-445-8798 · ewingp@ccf.org

  • Nationwide Children's Hospital

    Columbus, OH 43215

    Site contact: Victoria Shay · 614-355-5819 · victoria.shay@nationwidechildrens.org

  • Children's Hospital of Philadelphia

    Philadelphia, PA 19104

    Site contact: Faith Alunni · 570-430-5058 · alunnif@chop.edu

  • Children's Hospital of Pittsburgh

    Pittsburgh, PA 15224

    Site contact: Niklas Gerhart · 412-692-6742 · gerhartne4@upmc.edu

  • MUSC Pediatric Research Group

    Charleston, SC 29425

    Site contact: Susannah C Wakefield · 843-792-8317 · wakefies@musc.edu

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Sherry Bowman · 615-936-0061 · sherry.bowman@vumc.org

  • UT Southwestern Medical Center

    Dallas, TX 75235

    Site contact: Aruna Ayalasomayajula · 702-340-7830 · aruna.ayalasomayajula@utsouthwestern.edu

  • Texas Children's Hospital

    Houston, TX 77030

    Site contact: Sara Stephens · 832-826-5613 · sara.stephens@bcm.edu

  • Primary Children's Medical Center

    Salt Lake City, UT 84113

    Site contact: Andrea Dunn · 801-213-7609 · andrea.dunn@hsc.utah.edu

  • Seattle Children's Hospital

    Seattle, WA 98105

    Site contact: Ranjini Prakash · 206-987-2000 · Ranjini.Prakash@seattlechildrens.org

  • Children's Hospital of Wisconsin

    Milwaukee, WI 53226

    Site contact: Jennifer Yauck · 414-266-2325 · jyauck@childrenswi.org

Study contacts (from the official record)

  • WG Kim · 443.699.6746 · wgkim@mezzion.com
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Fontan Udenafil Exercise Longitudinal Assessment Trial - 2 (NCT05918211) | Bored Studies