Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02741115|
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Single Ventricle Heart Disease||Drug: Udenafil Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)|
|Actual Study Start Date :||July 22, 2016|
|Actual Primary Completion Date :||December 27, 2018|
|Actual Study Completion Date :||April 30, 2019|
Udenafil. One tablet twice daily for 26 weeks
Placebo. One tablet twice daily for 26 weeks
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741115
|Principal Investigator:||Steve Paridon, MD||Children's Hospital of Phildelphia|