Trial Condition(s):
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Hemodynamic and echocardiographic assessment of Riociguat effects on myocardial wall contractility and relaxation kinetics (HEARTWORK)
Bayer Identifier:
14549
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Massachusetts General Hospital Boston, United States, 02114-2696 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change in peak power index at restTimeframe: Before and 1 hour after administration of study drug
Secondary Outcome
- Change in left ventricular stroke work index (LVSWI) at restTimeframe: Before and 1 hour after administration of study drug
- Change in left ventricular ejection fraction (LVEF) at restTimeframe: Before and 1 hour after administration of study drug
- Change in end-systolic elastance at restTimeframe: Before and 1 hour after administration of study drug
- Change in peak power index during the cardiopulmonary exercise testsTimeframe: Before and 1 hour after administration of study drug
- Change in lateral mitral annular peak systolic velocity (Sm) during the cardiopulmonary exercise testsTimeframe: Before and 1 hour after administration of study drug
- Change in peak systolic tricuspid annular velocity (RV-Sm) during the cardiopulmonary exercise testsTimeframe: Before and 1 hour after administration of study drug
- Change in tricuspid annular plane systolic excursion (TAPSE) during the cardiopulmonary exercise testsTimeframe: Before and 1 hour after administration of study drug
- Change in lateral mitral annular peak early diastolic velocity (E’) during the cardiopulmonary exercise testsTimeframe: Before and 1 hour after administration of study drug
- Change in the slope of the relationship between work rate and mean pulmonary arterial pressure (PAPmean) during the cardiopulmonary exercise testsTimeframe: Before and 1 hour after administration of study drug
- 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
Additional Information
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