Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667

April 14, 2017 updated by: Bayer

Placebo Controlled, Randomized, Double-blind, Multi-center, Multinational Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 Given Intravenously in Patients With Decompensated Chronic Congestive Heart Failure

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Ste-Foy, Quebec, Canada, G1V 4G5
  • Croatia
      • Split, Croatia, 21000
      • Zagreb, Croatia, 10000
  • Czech Republic
      • Brno, Czech Republic, 625 00
      • Brno, Czech Republic, 656 91
      • Hradec kralove, Czech Republic, 500 05
      • Plzen, Czech Republic, 301 00
      • Praha 2, Czech Republic, 128 08
      • Praha 2, Czech Republic, 12808
  • Estonia
      • Tallin, Estonia, 13419
      • Tartu, Estonia, 51014
  • Germany
      • Berlin, Germany, 12200
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
    • Bayern
      • Würzburg, Bayern, Germany, 97080
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Bonn, Nordrhein-Westfalen, Germany, 53105
      • Köln, Nordrhein-Westfalen, Germany, 50924
    • Saarland
      • Homburg, Saarland, Germany, 66424
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
      • Jena, Thüringen, Germany, 07740
  • Hungary
      • Budapest, Hungary, H-1096
      • Debrecen, Hungary, 4032
      • Vac, Hungary, 2600
      • Zalaegerszeg, Hungary, 8900
  • Israel
      • Haifa, Israel, 34362
      • Jerusalem, Israel, 9112001
      • Ramat Gan, Israel, 5262000
      • Zefat, Israel, 1311001
  • Italy
      • Bergamo, Italy, 24128
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
      • Ferrara, Emilia-Romagna, Italy, 44100
    • Lombardia
      • Milano, Lombardia, Italy, 20162
      • Pavia, Lombardia, Italy, 27100
    • Umbria
      • Perugia, Umbria, Italy, 06156
  • Lithuania
      • Kaunas, Lithuania, 50009
      • Vilnius, Lithuania, 08661
  • Poland
      • Gdansk, Poland, 80-211
      • Krakow, Poland, 31-202
      • Szczecin, Poland, 70-111
      • Wroclaw, Poland, 50-981
      • Zabrze, Poland, 41-800
  • Russian Federation
      • Moscow, Russian Federation, 119435
      • Moscow, Russian Federation, 109263
      • Moscow, Russian Federation, 115093
      • Moscow, Russian Federation, 129010
  • Serbia
      • Beograd, Serbia, 11000
      • Sremska Kamenica, Serbia, 21204
  • Slovenia
      • Celje, Slovenia, 3000
      • Golnik, Slovenia, 4204
      • Ljubljana, Slovenia, 1000
      • Murska Sobota, Slovenia, 9000
  • Spain
      • Barcelona, Spain, 08036
      • Girona, Spain, 17007
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
  • Sweden
      • Göteborg, Sweden, 413 45
      • Uppsala, Sweden, 751 85
  • United Kingdom
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S44 5BL
    • Hertfordshire
      • Barnet, Hertfordshire, United Kingdom, EN5 3DJ
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
  • United States
    • California
      • San Diego, California, United States, 92103-8765
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Ohio
      • Cincinnati, Ohio, United States, 45219-2316
      • Fairfield, Ohio, United States, 45014
    • Texas
      • Dallas, Texas, United States, 75216-7167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP >/= 18 mmHg.
  • Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.
  • Male or female patients, age 18 years or more.

Exclusion Criteria:

  • Females of child-bearing potential.
  • Acute de-novo heart failure.
  • Acute myocardial infarction and/or myocardial infarction within 30 days.
  • Valvular heart disease requiring surgical intervention during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 2
Drug: Cinaciguat (BAY58-2667)
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Placebo Comparator: Arm 1
Drug: Placebo
Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Up to 30 days Follow-up
Up to 30 days Follow-up
Rehospitalization
Time Frame: Up to 30 days Follow-up
Up to 30 days Follow-up
Other hemodynamic measurements
Time Frame: Up to 48 hours
Right atrial pressure (RAP); mean pulmonary artery pressure (PAP mean); pulmonary artery systolic pressure (PASP); pulmonary artery diastolic pressure (PADP); cardiac output (CO); cardiac index (CI); mean arterial pressure (MAP); pulmonary vascular resistance (PVR); pulmonary vascular resistance index (PVRI); systemic vascular resistance (SVR); and systemic vascular resistance index (SVRI）
Up to 48 hours
Safety variables
Time Frame: Up to 30 days follow up
Treatment-emergent adverse events, laboratory parameters, renal function, in-hospital mortality, length of stay at intensive care unit, and 30-day mortality / morbidity.
Up to 30 days follow up
Plasma concentrations
Time Frame: During both the titration and maintenance phases were evaluated.
During both the titration and maintenance phases were evaluated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12480
  • 2007-003059-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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