NCT02310672

REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Macitentan	All patients take open-label macitentan 10mg o.d.

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-09-10
• Completion: 2019-09-10
• First posted: 2014-12-08
• Last updated: 2025-03-30
• Results posted: 2020-09-24

Locations

41 sites across 12 countries: United States, Australia, France, Germany, Hong Kong, Israel, Italy, Malaysia, Netherlands, Russia, Singapore, United Kingdom