Clinical trial NCT01065051: Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of a Single Dose of 1 mg Riociguat (BAY63-2521) on Myocardial Contractility and Relaxation in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (PH-sLVD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Ventricular Dysfunction, Left
Keywords: Pulmonary Hypertension
Left ventricular dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 1
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: The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Detailed description: Adverse event data will be covered in Adverse events section.

Eligibility criteria: Inclusion Criteria:

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy

Exclusion Criteria:

* Types of pulmonary hypertension other than group 2.1 of Dana Point Classification

Primary outcomes:
measure: Change in Peak Power Index at Rest
timeFrame: Before and 1 hour after administration of study drug
Secondary outcomes:
measure: Change in Left Ventricular Stroke Work Index (LVSWI) at Rest
timeFrame: Before and 1 hour after administration of study drug
measure: Change in Left Ventricular Ejection Fraction (LVEF) at Rest
timeFrame: Before and 1 hour after administration of study drug
measure: Change in End-systolic Elastance at Rest
timeFrame: Before and 1 hour after administration of study drug
measure: Change in Peak Power Index During the Cardiopulmonary Exercise Tests
timeFrame: Before and 1 hour after administration of study drug
measure: Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests
timeFrame: Before and 1 hour after administration of study drug
measure: Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests
timeFrame: Before and 1 hour after administration of study drug
measure: Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests
timeFrame: Before and 1 hour after administration of study drug
measure: Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E') During the Cardiopulmonary Exercise Tests
timeFrame: Before and 1 hour after administration of study drug
measure: Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests
timeFrame: Before and 1 hour after administration of study drug
measure: Change in the Ventilatory Efficiency (V'E/V'CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)
timeFrame: Before and 1 hour after administration of study drug
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: