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

NCT01065051 | Terminated Phase 2 Results

• 1 other identifier: 14549
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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

Conditions

Hypertension, Pulmonary; Ventricular Dysfunction, Left

Keywords

Pulmonary Hypertension; Left ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in Peak Power Index at Rest

  The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)\*CO \[cardiac output\]\*16.667/LVEDV

  Before and 1 hour after administration of study drug

Secondary Outcomes (10)

• Change in Left Ventricular Stroke Work Index (LVSWI) at Rest

  Before and 1 hour after administration of study drug

• Change in Left Ventricular Ejection Fraction (LVEF) at Rest

  Before and 1 hour after administration of study drug

• Change in End-systolic Elastance at Rest

  Before and 1 hour after administration of study drug

• Change in Peak Power Index During the Cardiopulmonary Exercise Tests

  Before and 1 hour after administration of study drug

• Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests

  Before and 1 hour after administration of study drug

Study Arms (2)

Riociguat (Adempas, BAY63-2521)

EXPERIMENTAL

Participants received a single oral dose of 1 mg riociguat.

Drug: Riociguat (Adempas, BAY63-2521)

Placebo

PLACEBO COMPARATOR

Participants received a single oral dose of 1 mg placebo.

Drug: Placebo

Interventions

Riociguat (Adempas, BAY63-2521) DRUG

1 mg single oral dose

Riociguat (Adempas, BAY63-2521)

Placebo DRUG

Single oral dose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy

You may not qualify if:

• Types of pulmonary hypertension other than group 2.1 of Dana Point Classification

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Boston, Massachusetts, 02114-2696, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Ventricular Dysfunction, Left

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Limitations and Caveats

The study was terminated prematurely due to low recruitment (one subject enrolled only). No statistical analyses of efficacy parameters were performed. Therefore, no clinically meaningful conclusions can be drawn from the data generated.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 6, 2014
• Results First Posted: January 6, 2014

Record last verified: 2013-12

Locations

US (2)