Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics (HEARTWORK)

This study has been terminated.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01065051

First received: February 8, 2010

Last updated: June 14, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2010

Last Updated Date

June 14, 2012

Start Date ^ICMJE

December 2010

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in peak power index at rest [ Time Frame: Before and 1 hour after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in peak power index at rest [ Time Frame: before and 1h after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01065051 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Indices of resting myocardial contractility [ Time Frame: Before and 1 hour after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]
Changes in myocardial contractility and lusitropy during exercise [ Time Frame: Before and 1 hour after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]
Relationship between pulmonary vasomotor tone, cardiac performance, and the regulation of ventilation [ Time Frame: Before and 1h after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]
Adverse event collection [ Time Frame: 7 days ± 3 days after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Indices of resting myocardial contractility [ Time Frame: Before and 1h after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]
Changes in myocardial contractility and lusitropy during exercise [ Time Frame: Before and 1h after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]
Relationship between pulmonary vasomotor tone, cardiac performance, and the regulation of ventilation [ Time Frame: Before and 1h after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: No ]
Adverse event collection [ Time Frame: 7 days ± 3 days after administration of a single dose of 1 mg Riociguat vs. placebo ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics

Official Title ^ICMJE

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)

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension, Pulmonary
Ventricular Dysfunction, Left

Intervention ^ICMJE

Drug: Riociguat (BAY63-2521)
1 mg single oral dose
Drug: Placebo
Single oral dose

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Riociguat (BAY63-2521)
Placebo Comparator: Arm 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01065051

Other Study ID Numbers ^ICMJE

14549

Has Data Monitoring Committee

Responsible Party

Head Clinical Pharmacology, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top