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)
Medical University of Vienna and AKH Cardiology
🇦🇹Vienna, Austria
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung
🇦🇹Linz, Austria
Ospedali Riuniti Di Trieste
🇮🇹Trieste, Italy
Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie
🇧🇪Brussels, Belgium
Houston Methodist Hospital - Heart Failure/Pulm Hypertension
🇺🇸Houston, Texas, United States
IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)
🇨🇿Praha, Czechia
Hospital Reina Sofia Servicio de Cardiologia
🇪🇸Cordoba, Spain
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, 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
University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
🇧🇪Leuven, Belgium
Vancouver General Hospital - The Lung
🇨🇦Vancouver, Canada
FN Brno-Bohunice, I. interní kardiologická klinika
🇨🇿Brno, Czechia
DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie
🇩🇪Berlin, Germany
FN Olomouc, 1. Interní klinika - kardiologická
🇨🇿Olomouc, Czechia
Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie
🇨🇿Praha, Czechia
Hôpital Charles Nicolle Service de Cardiologie
🇫🇷Rouen cedex, France
Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Innere Medizin III Kardiologie und Angiologie
🇩🇪Kiel, Germany
Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)
🇩🇪Köln, Germany
Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Großhadern Schwerpunkt Pneumologie
🇩🇪Munich, Germany
Carmel Medical Center, Pulmonary Unit
🇮🇱Haifa, Israel
Kaplan Medical Centre / Pulmonary Institute and Department of Medicine
🇮🇱Rehovot, Israel
Institute of Pulmonology Hadassah Medical Centre : Ein Karem
🇮🇱Jerusalem, Israel
A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia
🇮🇹Bologna, Italy
The Chaim Sheba Medical Center / The Institute of Pulmonology, Physiology and Exercise
🇮🇱Tel-Hashomer, Israel
Hospital Vall d´Hebron Servicio de Cardiologia
🇪🇸Barcelona, Spain
Hospital Clinic Servicio de Cardiologia
🇪🇸Barcelona, Spain
Hospital Universitario 12 Octubre Servicio de Cardiología
🇪🇸Madrid, Spain
Centre Hospitalier Universitaire Vaudois Service de Cardiologie
🇨🇭Lausanne, Switzerland
Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern
🇨🇭Bern, Switzerland