stop_circleTerminated/Withdrawn
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Bayer Identifier:
14549
ClinicalTrials.gov Identifier:
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
BothAge
18 YearsTrial summary
Enrollment Goal
1Trial Dates
November 2010 - January 2011Phase
Phase 2Could I Receive a placebo
YesProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Massachusetts General Hospital | Boston, 02114-2696, United States |
Terminated | Mayo Clinic - Rochester | Rochester, 55905, United States |
Primary Outcome
- Change in peak power index at restdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in left ventricular stroke work index (LVSWI) at restdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in left ventricular ejection fraction (LVEF) at restdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in end-systolic elastance at restdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in peak power index during the cardiopulmonary exercise testsdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in lateral mitral annular peak systolic velocity (Sm) during the cardiopulmonary exercise testsdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in peak systolic tricuspid annular velocity (RV-Sm) during the cardiopulmonary exercise testsdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in tricuspid annular plane systolic excursion (TAPSE) during the cardiopulmonary exercise testsdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in lateral mitral annular peak early diastolic velocity (E’) during the cardiopulmonary exercise testsdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- Change in the slope of the relationship between work rate and mean pulmonary arterial pressure (PAPmean) during the cardiopulmonary exercise testsdate_rangeTime Frame:Before and 1 hour after administration of study drugenhanced_encryptionNoSafety Issue:
- 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 drugenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2