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SOPRANO


Title 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
Therapeutic Area Hypertension, High Blood Pressure, Cardiovascular Disease
Principal Investigator Amanda Vest, MBBS
Min Age 18 Years
Gender All
Contact Corinne Pellows
617 636-4884
More Information https://clinicaltrials.gov/ct2/show/NCT02554903

Overview

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension (PH) after left ventricular assist device implantation. The purpose of this study is to evaluate the effect of the 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 study drug in subjects with PH after LVAD implantation. Macitentan is a study drug that works by blocking the effect of a substance called endothelin, which is produced in increased amounts in patients with pulmonary hypertension. Endothelin causes blood vessels to narrow (constrict), and overgrowth of the muscle in the walls of the blood vessels in the lung occurs. By blocking the action of endothelin, macitentan may reduce the blood pressure in the lung and improve activity level and wellbeing.In this study, half of the subjects will receive study drug/macitentan, while the other half of subjects will receive a placebo (inactive substance or sugar pill). he treatment period will last for about 12 weeks, with a follow-up period of 30 days. In total, including the screening period and a 30-day safety follow-up at the end of the study, the study will last no longer than 5.5 months, with up to 6 planned visits.

Study Details

Inclusion Criteria

  • Surgical implantation of LVAD (e.g., HeartMate II or HeartWare) within 45 days prior to Randomization.
  • Hemodynamic evidence of PH on Baseline right heart catheterization (RHC). Baseline RHC is defined as the last hemodynamic measurements after LVAD implantation and prior to Screening. Baseline RHC can be obtained via either routine RHC or pulmonary artery catheter. PH is defined as: Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and Pulmonary artery wedge pressure (PAWP) ≤ 18 mmHg
  • Stabilization of the patient after removal of the pulmonary artery catheter, defined as:
    • No LVAD pump speed/flow rate changes for 48 h prior to Screening and
    • Stable dose of diuretics for 48 h prior to Screening and
    • No intravenous (i.v.) inotropes or vasopressors for 48 hours (h) prior to Screening and
    • Patient able to ambulate 48 h prior to Screening.

Exclusion Criteria

  • Documented severe obstructive lung disease defined as: forced expiratory volume (FEV) in 1 second forced vital capacity (FEV1/FVC) < 0.7 associated with FEV1 < 50% of predicted value after bronchodilator administration.
  • GFR < 30 mL/min at Screening.
  • Known hypersensitivity to ERAs, or to any of the study treatment excipients

Study Requirements

The study will run for about 12 weeks, with a follow up period of 30 days. The study includes 6 planned visits. At these visits subjects will be asked to some or all of the following:
  • Questionnaires
  • Physical Exam
  • Blood Samples
  • Echocardiogram (a total of 3 Echocardiograms)
  • Right Heart Catheterization (a total of 3 Right Heart Catheterizations)
  • Drug dispense/ Drug return