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A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE EARLY)

This study has been terminated.
Information provided by (Responsible Party):
Bayer Identifier:
First received: February 4, 2010
Last updated: September 23, 2015
Last verified: October 2014
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 Intervention Phase
Heart Failure Heart Decompensation Drug: Cinaciguat (BAY58-2667) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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 BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Dyspnea VAS (using a visual analogue scale) [ Time Frame: 8 hours ]

Secondary Outcome Measures:
  • Dyspnea assessment (Likert Scale) [ Time Frame: up to follow-up (30 - 35 days) ]
  • Overall health status assessment (EQ-5D) [ Time Frame: up to follow-up (30 - 35 days) ]
  • Changes in the dyspnea VAS at other time points [ Time Frame: Up to follow up visit ]
  • Dyspnea assessment through Likert scale [ Time Frame: Up to follow up visit ]
  • Overall health status assessment through EQ-5D Health Questionnaire [ Time Frame: Up to the follow-up visit ]
  • Global clinical assessment by the physician [ Time Frame: At 8, 24, and 48 hours ]
  • Change in concomitant medications [ Time Frame: During the treatment ]
  • Safety variables [ Time Frame: Up to end of study ]
    Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment

Enrollment: 62
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h.
Experimental: Arm 2 Drug: Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
Experimental: Arm 3 Drug: Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
Placebo Comparator: Arm 4 Drug: Placebo
Infusion during 48h


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 ovarectomy, 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01064037

  Show 70 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01064037     History of Changes
Other Study ID Numbers: 14836
2009-017082-39 ( EudraCT Number )
Study First Received: February 4, 2010
Last Updated: September 23, 2015

Keywords provided by Bayer:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 21, 2017