BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065077
Recruitment Status : Terminated
First Posted : February 9, 2010
Last Update Posted : October 8, 2015
Information provided by (Responsible Party):

February 8, 2010
February 9, 2010
October 8, 2015
March 2010
January 2011   (Final data collection date for primary outcome measure)
Pulmonary Capillary Wedge Pressure [ Time Frame: 8 hours ]
Same as current
Complete list of historical versions of study NCT01065077 on Archive Site
  • Cardiac index (CI) [ Time Frame: 8 hours and 48 hours ]
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Follow up (30 + 5 days) ]
  • Right atrial pressure (RAP) [ Time Frame: 8 hours and 48 hours ]
Same as current
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BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Heart Failure
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 150 µg/h during 48h
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 100 µg/h during 48h
  • Drug: Cinaciguat (BAY58-2667)
    Infusion of 50 µg/h during 48h
  • Drug: Placebo
    Infusion of placebo during 48h
  • Experimental: Arm 1
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Experimental: Arm 2
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Experimental: Arm 3
    Intervention: Drug: Cinaciguat (BAY58-2667)
  • Placebo Comparator: Arm 4
    Intervention: Drug: Placebo
Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A; COMPOSE Investigators and Coordinators. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE programme in acute heart failure syndromes. Eur J Heart Fail. 2012 Sep;14(9):1056-66. Epub 2012 Jun 19.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
  • Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment
  • Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:

    • dyspnea and
    • clinical evidence of volume overload

Exclusion Criteria:

  • 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
  • Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
  • Primary hypertrophic cardiomyopathy
  • Acute inflammatory heart disease, eg, acute myocarditis
  • Unstable angina requiring angiography
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Croatia,   Finland,   Germany,   Israel,   Italy,   Japan,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Sweden,   Switzerland,   Thailand,   United States
2009-014377-40 ( EudraCT Number )
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Study Director: Bayer Study Director Bayer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP