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Placebo Controlled, Randomized, Double-Blind, Multi-Center Study to Investigate the Efficacy and Tolerability of BAY 58-2667

This study is currently recruiting participants.
Study NCT00559650.   Last updated on November 3, 2008.   Information provided by Bayer

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Descriptive Information Fields
Brief Title † Placebo Controlled, Randomized, Double-Blind, Multi-Center Study to Investigate the Efficacy and Tolerability of BAY 58-2667
Official Title † Placebo Controlled, Randomized, Double-Blind, Multi-Center, Multinational Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 Given Intravenously in Patients With Decompensated Chronic Congestive Heart Failure
Brief Summary

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY 58-2667) 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.
Detailed Description
Study Phase Phase II
Study Type † Interventional
Study Design † Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure † 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Quality of Life [ Time Frame: Up to 30 days Follow-up ] [ Designated as safety issue: No ]
Rehospitalization [ Time Frame: Up to 30 days Follow-up ] [ Designated as safety issue: No ]
Condition † Congestive Heart Failure
Intervention † Drug: Placebo
Drug: BAY 58-2667
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 210
Start Date † December 2007
Completion Date June 2009
Eligibility Criteria †

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Bayer Clinical Trials Contact         clinical-trials-contact@bayerhealthcare.com    
Contact: For trial location information (Phone Menu Options '3' or '4')     (+) 1-888-842-2937        
Location Countries † United States,   Canada,   Croatia,   Czech Republic,   Germany,   Hungary,   Israel,   Italy,   Poland,   Russian Federation,   Serbia,   Slovenia,   Spain,   Sweden,   United Kingdom
Administrative Information Fields
NCT ID † NCT00559650
Organization ID 12480
Secondary IDs †† EudraCT Nr: 2007-003059-36
Study Sponsor † Bayer
Collaborators ††
Investigators †
Study Director:     Bayer Study Director     Bayer    
Information Provided By Bayer
Verification Date November 2008
First Received Date † November 15, 2007
Last Updated Date November 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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