Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02310672
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2014-12-04
Brief Title:
REPAIR Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
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 Assessed by Cardiac Magnetic Resonance Imaging
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIR
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None