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A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE 2)

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: NCT01067859
Recruitment Status : Terminated
First Posted : February 12, 2010
Last Update Posted : October 8, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Drug: Cinaciguat (BAY58-2667) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Arm 1 Drug: Cinaciguat (BAY58-2667)
Infusion of 25 µg/h during 48 hours

Experimental: Arm 2 Drug: Cinaciguat (BAY58-2667)
Infusion of 10 µg/h during 48 hours

Placebo Comparator: Arm 3 Drug: Placebo
Infusion of placebo during 48 hours

Primary Outcome Measures :
  1. Pulmonary Capillary Wedge Pressure [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Cardiac index (CI) [ Time Frame: 8 hours and 48 hours ]
  2. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Follow up (after 30+5 days) ]
  3. Right atrial pressure (RAP) [ Time Frame: 8 hours and 48 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Congestive Heart Failure (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067859

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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Florida
Jacksonville, Florida, United States, 32209
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Ohio
Cincinnati, Ohio, United States, 45267-0542
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19141
Quilmes, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, 1078
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1039AAO
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1428DCO
Graz, Steiermark, Austria, 8020
Innsbruck, Tirol, Austria, 6020
Aalst, Belgium, 9300
Bruxelles - Brussel, Belgium, 1070
Leuven, Belgium, 3000
Creteil, France, 94010
PARIS cedex 10, France, 75475
Toulouse, France, 31403
Bad Krozingen, Baden-Württemberg, Germany, 79189
Bad Nauheim, Hessen, Germany, 61231
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Berlin, Germany, 12559
Dublin, Ireland, DUBLIN 9
Guadalajara, Jalisco, Mexico, 44280
Guadalajara, Jalisco, Mexico, 44670
Mexico D.F., México, Mexico, 57000
México D.F., Mexico
Quezon City, Philippines, 1102
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer Identifier: NCT01067859    
Other Study ID Numbers: 14663
2009-014378-16 ( EudraCT Number )
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: November 2014
Keywords provided by Bayer:
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases