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)

Bayer

Status and phase: Terminated; Phase 2

Conditions: Heart Decompensation; Heart Failure

Treatments: Drug: Cinaciguat (BAY58-2667); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064037

2009-017082-39 (EudraCT Number)

14836 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Cinaciguat (BAY58-2667)

Drug: Cinaciguat (BAY58-2667)

Drug: Cinaciguat (BAY58-2667)

Arm 2

Experimental group

Treatment:

Drug: Cinaciguat (BAY58-2667)

Drug: Cinaciguat (BAY58-2667)

Drug: Cinaciguat (BAY58-2667)

Arm 3

Experimental group

Treatment:

Drug: Cinaciguat (BAY58-2667)

Drug: Cinaciguat (BAY58-2667)

Drug: Cinaciguat (BAY58-2667)

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo