100
Participants
Start Date
August 1, 2022
Primary Completion Date
May 30, 2026
Study Completion Date
May 30, 2026
Mono-Therapy with Sildenafil
The subjects will be randomized to receive sildenafil alone and will undergo study procedures as outlined in section 1.3. There will not be a placebo group.
Duo-Therapy with Sildenafil + Bosentan
The subjects will be randomized to receive combination up-front therapy sildenafil and bosentan and will undergo study procedures as outlined in section 1.3. There will not be a placebo group.
Columbia University Medical Center, New York
New York Medical College, Valhalla
Johns Hopkins Medical Institutions, Baltimore
Johns Hopkins All Children's Hospital, St. Petersburg
Vanderbilt University Medical Center, Nashville
Medical College of Wisconsin, Milwaukee
Baylor College of Medicine, Houston
Children's Hospital Colorado, Aurora
Seattle Children's Hospital, Seattle
Boston Children's Hospital, Boston
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
Johns Hopkins University
OTHER