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

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Bayer

Status and phase

Terminated
Phase 2

Conditions

Ventricular Dysfunction, Left
Hypertension, Pulmonary

Treatments

Drug: Riociguat (Adempas, BAY63-2521)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01065051
14549

Details and patient eligibility

About

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

Full description

Adverse event data will be covered in Adverse events section.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1 participants in 2 patient groups, including a placebo group

Riociguat (Adempas, BAY63-2521)
Experimental group
Description:
Participants received a single oral dose of 1 mg riociguat.
Treatment:
Drug: Riociguat (Adempas, BAY63-2521)
Placebo
Placebo Comparator group
Description:
Participants received a single oral dose of 1 mg placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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