What this study is
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.
What's being tested
- Udenafil
Intervention · DRUG
Active drug
- Placebo
Intervention · DRUG
Matching Placebo
Study details
- Official title
- Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)
- Sponsor
- Mezzion Pharma Co. Ltd
- Conditions
- Single Ventricle Heart Disease
- Enrolling
- 436 people
- Starts
- 2023-10-30
- Est. completion
- 2025-10-28
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (40)
40 openPhoenix Children's Hospital
Phoenix, Arizona, United States
- Jade Porche · Contact602-933-6835jporche@phoenixchildrens.com
- Arash Sabati, MD · Principal investigator
RecruitingArkansas Children's
Little Rock, Arkansas, United States
- Wendy Haley · Contact501-364-2237haleyw@archildren's.org
- Dala Zakaria, MD · Principal investigator
RecruitingChildren's Hospital of Los Angeles
Los Angeles, California, United States
- Matthew Dam · Contact323-361-7881mdam@chla.usc.edu
- Jon Detterich, MD · Principal investigator
RecruitingRady Children's Hospital
San Diego, California, United States
- Mark Abcede · Contact619-987-0650mabcede1@rchsd.org
- Jessica Haley, MD · Principal investigator
RecruitingUCSF Benioff Children's Hospital
San Francisco, California, United States
- Aisling Conneally · Contact510-600-2965aisling.conneally@ucsf.edu
- Doaa Aly, MD · Principal investigator
RecruitingChildren's Hospital of Colorado
Denver, Colorado, United States
- Andrea DeMarsh · Contact216-906-7931andrea.demarsh@childrenscolorado.org
- Roni Jacobsen · Principal investigator
RecruitingYale School of Medicine
New Haven, Connecticut, United States
- Amanda Catucci · Contact631-897-6722amanda.catucci@yale.edu
- Meredith Leslie, MD · Principal investigator
RecruitingNemours Children's Hospital
Wilmington, Delaware, United States
- Carol Prospero · Contact302-651-6686carol.prospero@nemours.org
- Mark Cartoski, MD · Principal investigator
RecruitingChildrens National Medical Center
Washington D.C., District of Columbia, United States
- Stacy Davenport · Contact240-547-9804amatthews@childrensnational.org
- Sairah Khan, MD · Principal investigator
RecruitingUF Health Shands Hospital
Gainesville, Florida, United States
- Dalia Lopez-Colon · Contact352-281-6723dalylc@ufl.edu
- Dipankar Gupta, MD · Principal investigator
RecruitingJoe DiMaggio Children's Hospital
Hollywood, Florida, United States
- Norma Barton · Contact954-265-4466NBarton@mhs.net
- Melissa Diamond, MD · Principal investigator
RecruitingJohns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
- Lexie Dallas · Contact727-767-2465adallas@jhmi.edu
- Jamie Decker, MD · Principal investigator
RecruitingChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
- Jessica Braun · Contact404-785-3828jessica.braun@choa.org
- Michael Lopez, MD · Principal investigator
RecruitingChildren's Hospital of Georgia
Augusta, Georgia, United States
- Michelle Collins · Contact706-721-9680MCOLLINS2@augusta.edu
- Mark Vranicar, MD · Principal investigator
RecruitingLurie Children's Hospital
Chicago, Illinois, United States
- Jessica Bhavsar · Contact312-227-4432jbhavsar@luriechildrens.org
- Kendra Ward, MD · Principal investigator
RecruitingUniversity of Chicago
Chicago, Illinois, United States
- Becky Puplava · Contact773-702-2879rpuplava@bsd.uchicago.edu
- Michael Earing, MD · Principal investigator
RecruitingBoston Children's Hospital
Boston, Massachusetts, United States
- Tom Giorgio · Contact617-355-4201thomas.giorgio@cardio.chboston.org
- Rahul Rathod, MD · Principal investigator
RecruitingUniversity of Michigan
Ann Arbor, Michigan, United States
- Cynthia Smith · Contact734-615-0590csmithw@med.umich.edu
- Kurt Schumacher, MD · Principal investigator
RecruitingChildren's Mercy Hospital Kansas City
Kansas City, Missouri, United States
- Dara Watkins · Contact816-302-3633djwatkins@cmh.org
- Jonathan B Wagner, MD · Principal investigator
RecruitingWashington University
St Louis, Missouri, United States
- Mason Basler · Contact618-579-5674basler@wustl.edu
- William Orr, MD · Principal investigator
RecruitingUniversity of Nebraska Children's Hospital and Medical Center
Omaha, Nebraska, United States
- Morgan Loeffelbein · Contact402-559-0681mloeffelbein@unmc.edu
- Angela Yetman, MD · Principal investigator
RecruitingMt. Sinai Children's Hospital
New York, New York, United States
- Xueru Mu · Contact347-335-7148xueru.mu@mssm.edu
- Neha Bansel, MD · Principal investigator
Not yet recruitingNew York-Presbyterian Children's Hospital
New York, New York, United States
- Katrina Golub · Contact212-342-1562kg2697@cumc.columbia.edu
- Christopher Petit, MD · Principal investigator
RecruitingDana.Amaro@atriumhealth.org
Charlotte, North Carolina, United States
- Dana Amaro · Contact704-355-4692dana.amaro@atriumhealth.org
- Matthew Schwartz, MD · Principal investigator
Not yet recruitingDuke University Medical Center
Durham, North Carolina, United States
- Alexi Pifer · Contactalexis.pifer@duke.edu
- Melissa Harward · Contactmelissa.harward@duke.edu
- Gregory Fleming, MD · Principal investigator
RecruitingCincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
- Mariah Palmer · Contact513-636-9516Mariah.Palmer@cchmc.org
- Sasha Opotowsky, MD · Principal investigator
RecruitingCleveland Clinic
Cleveland, Ohio, United States
- Ewing Paige · Contact216-445-8798ewingp@ccf.org
- Shahnawaz Amdani, MD · Principal investigator
RecruitingNationwide Children's Hospital
Columbus, Ohio, United States
- Victoria Shay · Contact614-355-5819victoria.shay@nationwidechildrens.org
- Omar Khalid, MD · Principal investigator
RecruitingChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
- Faith Alunni · Contact570-430-5058alunnif@chop.edu
- Jon Edelson, MD · Principal investigator
RecruitingChildren's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Niklas Gerhart · Contact412-692-6742gerhartne4@upmc.edu
- Lauren Carlozzi, MD · Principal investigator
RecruitingMUSC Pediatric Research Group
Charleston, South Carolina, United States
- Susannah C Wakefield · Contact843-792-8317wakefies@musc.edu
- Andrew Atz, MD · Principal investigator
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
- Sherry Bowman · Contact615-936-0061sherry.bowman@vumc.org
- Benjamin Frischhertz, MD · Principal investigator
RecruitingUT Southwestern Medical Center
Dallas, Texas, United States
- Aruna Ayalasomayajula · Contact702-340-7830aruna.ayalasomayajula@utsouthwestern.edu
- Matt Lemler, MD · Principal investigator
RecruitingTexas Children's Hospital
Houston, Texas, United States
- Sara Stephens · Contact832-826-5613sara.stephens@bcm.edu
- Daniel Penny, MD · Principal investigator
RecruitingPrimary Children's Medical Center
Salt Lake City, Utah, United States
- Andrea Dunn · Contact801-213-7609andrea.dunn@hsc.utah.edu
- Richard Williams, MD · Principal investigator
RecruitingSeattle Children's Hospital
Seattle, Washington, United States
- Ranjini Prakash · Contact206-987-2000Ranjini.Prakash@seattlechildrens.org
- Matthew Files, MD · Principal investigator
RecruitingChildren's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
- Jennifer Yauck · Contact414-266-2325jyauck@childrenswi.org
- Stephanie Handler, MD · Principal investigator
Recruiting
3 sites outside the US
Sejong General Hospital
Bucheon-si, Gyeonggi-do, South Korea
- Jiyeun Jeong · Contact010-9221-5114seize86@naver.com
- Yubin Min · Contact032-340-1782yubin0812@naver.com
- Seongho Kim, MD · Principal investigator
RecruitingSeoul National University Children's Hospital
Seoul, South Korea
- Gowoon Choi · Contactgo9979@snu.ac.kr
- Gibeom Kim, MD · Principal investigator
RecruitingYonsei Severance Hospital
Seoul, South Korea
- Juwon Heo · Contactjwheo92@yuhs.ac
- Saeyong Jung, MD · Principal investigator
Recruiting
Study team
Sponsor
Mezzion Pharma Co. Ltd
Study ID MZ_Udenafil-05
Study director
WG Kim
Mezzion Pharma Co. Ltd
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.