Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Macitentan 10 mg, oral tablet, to be taken once daily.
Matching placebo oral tablet, to be taken once daily.
Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.
The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.
Time frame: From baseline to Week 16
Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).
The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time frame: From baseline to Week 24
Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).
This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 24 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.
Time frame: From baseline to Week 24
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional classes are defined as follows: 1) class I: no symptoms with exercise or at rest. No limitation of activity. 2) class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). 3) class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. 4) class IV: symptoms at rest (such as dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms (e.g. may faint especially while bending over with their heads lowered). Patients in class IV manifest signs of right heart failure. Shifting to a higher class (e.g. from class III to class IV) represents a 'worsening' while shifting to a lower class (e.g. from class III to class II) means an 'improvement'.
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University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
Leuven, Belgium
Beijing Chao-Yang Hospital-Department of Respiration
Beijing, China
Cardiovascular institute & Fuwai Hospital- Thrombus Center
Beijing, China
The first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, China
ngShanghai Pulmonary Hospital, Department of Pulmonary Circulation
Shanghai, China
The General Hospital of Shenyang Military Region,Congenital Heart Disease Department
Shenyang, China
Wuhan Asia Heart Hospital
Wuhan, China
Centre for PPH, Charles University , II Interni klinika1.LF a VFN
Prague, Czechia
CHU de Bicêtre
Le Kremlin-Bicêtre, France
Hôpital Européen Georges Pompidou Service de Pneumologie, soins intensifs et endoscopies bronchiques
Paris, France
...and 26 more locations
Time frame: From baseline to Week 24