Actively Recruiting
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Led by Mezzion Pharma Co. Ltd · Updated on 2025-10-28
436
Participants Needed
40
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Height less than 132 cm.
- Weight less than 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 with mean gradient over 4 mmHg between proximal and distal regions.
- Single lung physiology with greater than 80% flow to one lung.
- Failure to achieve maximal exertion (RER less than 1.10) on screening/baseline exercise test.
- Peak minute oxygen consumption (VO2) less than 45% or greater or equal to 80% of predicted for age and gender at enrollment.
- Severe ventricular dysfunction assessed by echocardiography within 6 months prior to enrollment.
- Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by echocardiography within 6 months prior to enrollment.
- History of significant renal, hepatic, gastrointestinal or biliary disorders that impair oral medication absorption, metabolism or excretion.
- Inability to complete exercise testing at baseline screening.
- Subjects with a pacemaker whose heart rate at peak exercise is controlled by the pacemaker rather than native rhythm.
- History of PDE-5 inhibitor use within 12 months prior to enrollment.
- History of other pulmonary hypertension medications within 3 months before study.
- Known intolerance to oral udenafil.
- Frequent use of medications or substances that affect CYP3A4 enzyme.
- Current use of alpha-blockers or nitrates.
- Ongoing or planned participation in another research protocol affecting study completion.
- Noncardiac medical, psychiatric, or social disorder that prevents study completion.
- Cardiac care at non-study center that impedes study completion.
- For females: pregnancy at screening, planned pregnancy before study end, or refusal to use contraception if sexually active.
- Unable to abstain or limit grapefruit juice and grapefruit drinks during the trial.
- Refusal to provide written informed consent/assent.
- Likely non-compliance with study protocol.
- History of clinically significant thromboembolic event that increases risk during study.
- COVID-19 vaccination or symptoms within 7 days of Visit 1.
- Not taking antiplatelet or anticoagulant therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Arkansas Children's
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
5
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
Actively Recruiting
6
Children's Hospital of Colorado
Denver, Colorado, United States, 80045
Actively Recruiting
7
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
8
Nemours Children's Hospital
Wilmington, Delaware, United States, 19803
Actively Recruiting
9
Childrens National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
10
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
11
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
12
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
13
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
14
Children's Hospital of Georgia
Augusta, Georgia, United States, 30912
Actively Recruiting
15
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
16
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
18
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
19
Children's Mercy Hospital Kansas City
Kansas City, Missouri, United States, 64108
Actively Recruiting
20
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
21
University of Nebraska Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
22
Mt. Sinai Children's Hospital
New York, New York, United States, 10029
Not Yet Recruiting
23
New York-Presbyterian Children's Hospital
New York, New York, United States, 10032
Actively Recruiting
24
Dana.Amaro@atriumhealth.org
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
25
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
26
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Actively Recruiting
27
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
28
Nationwide Children's Hospital
Columbus, Ohio, United States, 43215
Actively Recruiting
29
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
31
MUSC Pediatric Research Group
Charleston, South Carolina, United States, 29425
Actively Recruiting
32
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
33
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
34
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
35
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Actively Recruiting
36
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
37
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
38
Sejong General Hospital
Bucheon-si, Gyeonggi-do, South Korea, 14754
Actively Recruiting
39
Seoul National University Children's Hospital
Seoul, South Korea, 03080
Actively Recruiting
40
Yonsei Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
W
WG Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here