stop_circleTerminated/Withdrawn

Hypertension, Pulmonary, Ventricular Dysfunction, Left

Bayer Identifier:

14549

ClinicalTrials.gov Identifier:

NCT01065051

EudraCT Number:

Not Available

EU CT Number:

Not Available
Hemodynamic and echocardiographic assessment of Riociguat effects on myocardial wall contractility and relaxation kinetics

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy
  • - Types of pulmonary hypertension other than group 2.1 of Dana Point Classification

Trial summary

Enrollment Goal
1
Trial Dates
November 2010 - January 2011
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Massachusetts General HospitalBoston, 02114-2696, United States
Terminated
Mayo Clinic - RochesterRochester, 55905, United States

Primary Outcome

  • Change in peak power index at rest
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in left ventricular stroke work index (LVSWI) at rest
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in left ventricular ejection fraction (LVEF) at rest
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in end-systolic elastance at rest
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in peak power index during the cardiopulmonary exercise tests
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in lateral mitral annular peak systolic velocity (Sm) during the cardiopulmonary exercise tests
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in peak systolic tricuspid annular velocity (RV-Sm) during the cardiopulmonary exercise tests
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in tricuspid annular plane systolic excursion (TAPSE) during the cardiopulmonary exercise tests
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in lateral mitral annular peak early diastolic velocity (E’) during the cardiopulmonary exercise tests
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in the slope of the relationship between work rate and mean pulmonary arterial pressure (PAPmean) during the cardiopulmonary exercise tests
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No
  • Change in the ventilatory efficiency (V’E/V’CO2) measured from baseline to the anaerobic threshold (AT) during the cardiopulmonary exercise tests (CPET)
    date_rangeTime Frame:
    Before and 1 hour after administration of study drug
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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