Clinical trial NCT02070991: 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
Official title: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: pre- and post-capillary pulmonary hypertension
CpcPH
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Males and Females \>=18 years of age
2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
3. Optimized diuretic therapy

Exclusion Criteria:

1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
2. Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)

Primary outcomes:
measure: Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
timeFrame: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day
Secondary outcomes:
measure: NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest
timeFrame: From randomization up to end of treatment period (Week 12)
measure: PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest
timeFrame: From randomization up to end of treatment period (Week 12)
measure: Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
timeFrame: From randomization up to end of treatment period (Week 12)
measure: Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
timeFrame: From randomization up to end of treatment period (Week 12)
measure: Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)
timeFrame: From randomization up to end of treatment period (Week 12)
measure: Change From Baseline to Week 12 in Cardiac Index (CI)
timeFrame: From randomization up to end of treatment period (Week 12)
measure: Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)
timeFrame: From randomization up to end of treatment period (Week 12)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Center for Advanced Med
state: Missouri
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Houston
country: United States
facility: Houston Methodist Hospital - Heart Failure/Pulm Hypertension
state: Texas
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung
city: Vienna
country: Austria
facility: Medical University of Vienna and AKH Cardiology
city: Brussels
country: Belgium
facility: Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
city: Vancouver
country: Canada
facility: Vancouver General Hospital - The Lung
city: Brno
country: Czechia
facility: FN Brno-Bohunice, I. interní kardiologická klinika
city: Olomouc
country: Czechia
facility: FN Olomouc, 1. Interní klinika - kardiologická
city: Praha
country: Czechia
facility: IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)
city: Praha
country: Czechia
facility: Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie
city: Rouen cedex
country: France
facility: Hôpital Charles Nicolle Service de Cardiologie
city: Berlin
country: Germany
facility: DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie
city: Kiel
country: Germany
facility: Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Innere Medizin III Kardiologie und Angiologie
city: Köln
country: Germany
facility: Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)
city: Munich
country: Germany
facility: Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Großhadern Schwerpunkt Pneumologie
city: Haifa
country: Israel
facility: Carmel Medical Center, Pulmonary Unit
city: Jerusalem
country: Israel
facility: Institute of Pulmonology Hadassah Medical Centre : Ein Karem
city: Rehovot
country: Israel
facility: Kaplan Medical Centre / Pulmonary Institute and Department of Medicine
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center / The Institute of Pulmonology, Physiology and Exercise
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia
city: Trieste
country: Italy
facility: Ospedali Riuniti Di Trieste
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron Servicio de Cardiologia
city: Barcelona
country: Spain
facility: Hospital Clinic Servicio de Cardiologia
city: Cordoba
country: Spain
facility: Hospital Reina Sofia Servicio de Cardiologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 Octubre Servicio de Cardiología
city: Bern
country: Switzerland
facility: Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois Service de Cardiologie
Study officials:
affiliation: Actelion
name: Sébastien Roux, PhD
role: STUDY_CHAIR
References: