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REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

NCT02310672 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-03-30

Study results available
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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

Interventions

DRUG

Macitentan

All patients take open-label macitentan 10mg o.d.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Loïc Perchenet · Actelion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2019-09-10
Completion
2019-09-10

Countries

  • United States
  • Australia
  • France
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Russia
  • Singapore
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02310672 on ClinicalTrials.gov