Clinical Trial: REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
Brief 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.
Detailed Summary:
Sponsor: Actelion
Current Primary Outcome: To evaluate the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension (PAH). [ Time Frame: Baseline to Week 26 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To investigate the effect of macitentan on ventriculo-arterial coupling in patients with symptomatic PAH. [ Time Frame: baseline to Week 26 ]Change in arterial elastance
- To evaluate the safety and tolerability of macitentan in patients with symptomatic PAH. [ Time Frame: Base line to 30 days after End of Treatment (Week 52) ]Treatment-emergent adverse events (AEs) up to 30 days after EOT.
Original Secondary Outcome: Same as current
Information By: Actelion
Dates:
Date Received: December 4, 2014
Date Started: June 1, 2015
Date Completion: May 31, 2019
Last Updated: May 19, 2017
Last Verified: May 2017