Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
- Registration Number
- NCT02070991
- Lead Sponsor
- Actelion
- Brief Summary
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Males and Females >=18 years of age
- Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
- Optimized diuretic therapy
- Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
- Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Macitentan Macitentan oral tablet, 10 mg once daily. Placebo Placebo Matching placebo, once daily.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
- Secondary Outcome Measures
Name Time Method PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest From randomization up to end of treatment period (Week 12) Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) From randomization up to end of treatment period (Week 12) Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP) From randomization up to end of treatment period (Week 12) NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest From randomization up to end of treatment period (Week 12) Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) From randomization up to end of treatment period (Week 12) Change From Baseline to Week 12 in Cardiac Index (CI) From randomization up to end of treatment period (Week 12) Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG) From randomization up to end of treatment period (Week 12)
Trial Locations
- Locations (32)
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine - Center for Advanced Med
🇺🇸Saint Louis, Missouri, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Houston Methodist Hospital - Heart Failure/Pulm Hypertension
🇺🇸Houston, Texas, United States
Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung
🇦🇹Linz, Austria
Medical University of Vienna and AKH Cardiology
🇦🇹Vienna, Austria
Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie
🇧🇪Brussels, Belgium
University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
🇧🇪Leuven, Belgium
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