SOPRANO Clinical Trial

Condition: Pulmonary hypertension

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Surgical implantation of LVAD
  • Evidence of pulmonary hypertension on baseline right heart catheterization

Key Exclusion Criteria

  • Documented severe obstructive lung disease
  • Documented moderate to severe restrictive lung disease
  • Documented pulmonary veno-occlusive disease

Full Study Name

A Prospective, Multi-Center, 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 no. 41685)

Summary

The purpose of this study is to evaluate the safety and effects of an investigational drug called macitentan in patients with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. Pulmonary hypertension is a disorder of the blood vessels of the lungs, which can occur or worsen after implantation of an LVAD. Researchers will assess the effects of macitentan on the properties and function of the heart, as well as on blood pressure in the pulmonary arteries.


Principal Investigator

Jaime Moriguchi, MD

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