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

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

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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