REPAIR-Right vEntricular remodeling in Pulmonary ArterIal hypeRtension
Research type
Research Study
Full 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 assessed by cardiac magnetic resonance imaging
IRAS ID
173811
Contact name
Loïc Perchenet
Contact email
Sponsor organisation
ACTELION Pharmaceuticals Ltd
Eudract number
2014-004066-20
Research summary
This is a prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effect of Macitentan on the properties and function of the heart and on the blood pressure in the pulmonary arteries.
Men and women aged 18-65 with WHO group I Pulmonary Arterial Hypertention (PAH), in accordance with the approved indication for Macitentan, will be included in this study. A total of approximately 100 patients will be enrolled in approximately, 45 hospitals in Australia, Europe and North America. The study will last for about two years, with patient’s participation lasting for about 1 year and 2 months.
In some hospitals involved in the above main study, participants will be asked to participate in one of three sub-studies as well. These include: Metabolism sub-study (to be conducted in the US only), the Biopsy sub-study and Echo sub study.
For the Biopsy sub study 10 to 20 patients eligible for the main study. For this sub-study, patients with PAH etiology belonging to Nice classification 1.4.4 (PAH associated with congenital heart diseases) are excluded because their endomyocardium presents differences from the endomyocardium in the other etiologies enrolled in the study The objective of this study is to assess the histological and biochemical effects of Macitentan on the endomyocardium of the interventricular septum in patients with symptomatic PAH.
For the Echo sub-study10 to 20 patients eligible for the main study, may participate. The objective of this study to assess the effect of Macitentan on right and left ventricular function by echocardiography in patients with symptomatic PAH.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0117
Date of REC Opinion
14 May 2015
REC opinion
Further Information Favourable Opinion