SOPRANO, #AC-055-205: A prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation.
IRB Protocol #: 1509016535
Overview: The purpose of this clinical research study is to evaluate the effect of the research study drug, macitentan on the properties and function of the heart and on the blood pressure in the pulmonary arteries and to find out more about the safety of the research study drug in subjects with PH after LVAD implantation.
This trial is funded byActelion Pharmaceuticals US, Inc.
Patients must have:
- Surgical implantation of LVAD within 90 days prior to Randomization
- Hemodynamic evidence of PH on Baseline right heart catheterization (RHC) by the thermodilution method. (Baseline RHC is defined as the last hemodynamic measurements after LVAD implantation and prior to the first dose of study treatment.)
Patients cannot participate if they have:
- Treatment with another investigational drug (planned, or taken) within 28 days prior to study treatment initiation
- Known hypersensitivity to ERAs, or to any of the study treatment excipients.
Dr. Evelyn Horn
Phone: (212) 746-2381
Melissa Ricketts, MSHS, CCRC
Phone: (212) 746-2698