The primary objective of this study is to • Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary hypertension and heart failure with preserved ejection fraction The secondary objectives of this study are to * Assess safety and tolerability of riociguat in this study population * Assess changes in dimensions of left and right ventricles and cardiac function parameters using cardiac magnetic resonance imaging
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
118
Adempas up-titrated to max. 1.5mg TID
Placebo sham-titrated TID
Medical University of Vienna
Vienna, Austria
Change from baseline of cardiac output at rest, measured by right heart catheterization
Change from baseline of cardiac output at rest, measured by right heart catheterization after 26 weeks of study drug treatment
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in cardiac magnetic resonance imaging parameters
Change from baseline in right ventricular ejection fraction by cardiac magnetic resonance imaging
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in cardiac magnetic resonance imaging parameters
Change from baseline in right ventricular volume by cardiac magnetic resonance imaging
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in cardiac magnetic resonance imaging parameters
Change from baseline in left atrial area by cardiac magnetic resonance imaging
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in cardiac magnetic resonance imaging parameters
Change from baseline in right atrial area by cardiac magnetic resonance imaging
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in hemodynamic parameters other than cardiac output
Change from baseline in pulmonary vascular resistance by right heart catheterization
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in hemodynamic parameters other than cardiac output
Change from baseline in pulmonary arterial wedge pressure by right heart catheterization
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in hemodynamic parameters other than cardiac output
Change from baseline in transpulmonary gradient by right heart catheterization
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in hemodynamic parameters other than cardiac output
Change from baseline in systemic vascular resistance by right heart catheterization
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in WHO functional class
Time frame: Baseline and 26 weeks after study drug treatment
Change from baseline in biomarker levels
Change from baseline in serum N-terminal prohormone B-type natriuretic peptide (NTproBNP)
Time frame: Baseline and 26 weeks after study drug treatment
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