A prospective, multicenter, double-blind, randomized, placebocontrolled, 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.
Phase 2
Recruiting
- Conditions
- eft Ventricular DysfunctionPost-capillary Pulmonary HypertensionPre-capillary Pulmonary HypertensionI50.12I50.13I27.28
- Registration Number
- DRKS00007158
- Lead Sponsor
- Actelion Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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 pulmonary arterial hypertension-specific therapy (i.e., endothelin receptor antagonists (ERAs), prostanoids, phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects experiencing one of the following up to end-of-treatment:<br>-Significant fluid retention, defined as one of the following:<br>a) Increase in body weight at any time by = 5% or = 5 kg from baseline due to fluid overload.<br>b) Parenteral administration of diuretics.<br>-Worsening in NYHA functional class from baseline.
- Secondary Outcome Measures
Name Time Method Main secondary endpoints:<br>- pulmonary vascular resistance at rest at Week 12 expressed as percent of baseline value at rest. <br>-Change from baseline to Week 12 in mean right atrial pressure, mean pulmonary artery pressure, cardiac index, cardiac output, total pulmonary resistance, transpulmonary gradient, diastolic pulmonary pressure gradient, and mixed venous oxygen saturation at rest. <br>- change from baseline to Week 12 in echocardiographic parameters of diastolic and systolic function (i.e., left ventricular ejection fraction, tricuspid annular plane systolic excursion, tricuspid regurgitation velocity, diastolic wall thickness of the septum and the left ventricular free wall, E/e' ratio, left atrial volume).<br>