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Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

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ClinicalTrials.gov Identifier: NCT02741115
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mezzion Pharma Co. Ltd

Tracking Information
First Submitted Date  ICMJE April 10, 2016
First Posted Date  ICMJE April 18, 2016
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE July 22, 2016
Actual Primary Completion Date December 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
Change in Exercise Capacity [ Time Frame: Baseline to 26 Weeks ]
The change in exercise capacity (as measured by maximal VO2 at maximum exercise effort) from baseline to 26 weeks (or study completion)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
  • Change in Myocardial Performance Index (MPI) [ Time Frame: Baseline to 26 weeks ]
    The change in the myocardial performance index (MPI) from baseline to 26 weeks determined by velocities obtained from blood pool Doppler assessment of the inflow and outflow tract of the dominant ventricle.
  • Change in log-transformed reactive hyperemia index (InRH) [ Time Frame: Baseline to 26 weeks ]
    The change in log-transformed reactive hyperemia index (lnRHI) from baseline to 26 weeks as measured by pulse amplitude tonometry (PAT) testing using the EndoPAT® device.
  • Change in Level of Serum serum brain-type natriuretic peptide BNP [ Time Frame: Baseline to 26 weeks ]
    Change in Level of Serum serum brain-type natriuretic peptide BNP from baseline to 26 weeks.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
  • Change in Myocardial Performance Index (MPI) [ Time Frame: Baseline to 26 weeks ]
    The change in the myocardial performance index (MPI) from baseline to 26 weeks determined by velocities obtained from blood pool Doppler assessment of the inflow and outflow tract of the dominant ventricle.
  • Change in log-transformed reactive hyperemia indes (InRH) [ Time Frame: Baseline to 26 weeks ]
    The change in log-transformed reactive hyperemia index (lnRHI) from baseline to 26 weeks as measured by pulse amplitude tonometry (PAT) testing using the EndoPAT® device.
  • Change in Level of Serum serum brain-type natriuretic peptide BNP [ Time Frame: Baseline to 26 weeks ]
    Change in Level of Serum serum brain-type natriuretic peptide BNP from baseline to 26 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fontan Udenafil Exercise Longitudinal Assessment Trial
Official Title  ICMJE Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
Brief Summary 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 subjects who have undergone the Fontan procedure.
Detailed Description This study is a randomized, double-blinded, efficacy trial of the effects of udenafil vs. placebo on the background of standard therapy on maximal VO2 (ml/kg/min) from baseline to six months in adolescent survivors of the Fontan procedure. . The target sample size is 400 subjects (200 per group).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Single Ventricle Heart Disease
Intervention  ICMJE
  • Drug: Udenafil
    Active drug
  • Drug: Placebo
    Matching Placebo
Study Arms  ICMJE
  • Experimental: Drug
    Udenafil. One tablet twice daily for 26 weeks
    Intervention: Drug: Udenafil
  • Experimental: Placebo
    Placebo. One tablet twice daily for 26 weeks
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date December 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Weight < 40 kg
  2. Height < 132 cm.
  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 3 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 mmHg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography, obtained prior to screening for the trial.
  8. Single lung physiology with greater than 80% flow to one lung.
  9. VO2 less than 50%
  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 (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, based on laboratory assessment six weeks prior to screening for the trial.
  13. Inability to complete exercise testing at baseline screening.
  14. History of PDE-5 inhibitor use within 3 months before study onset.
  15. History of any other medication for treatment of 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 if sexually active.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02741115
Other Study ID Numbers  ICMJE PHN-Udenafil-02
U01HL068270 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Mezzion Pharma Co. Ltd
Study Sponsor  ICMJE Mezzion Pharma Co. Ltd
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Steve Paridon, MD Children's Hospital of Phildelphia
PRS Account Mezzion Pharma Co. Ltd
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP