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)

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01067859

Acronym

COMPOSE 2

Enrollment

Registered

2010-02-12

Start date

2010-03-31

Completion date

2010-11-30

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

Keywords

Heart Failure

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.

Interventions

DRUGCinaciguat (BAY58-2667)

Infusion of 25 µg/h during 48 hours

DRUGPlacebo

Infusion of placebo during 48 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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

Design outcomes

Primary

Measure	Time frame
Pulmonary Capillary Wedge Pressure	8 hours

Secondary

Measure	Time frame
Cardiac index (CI)	8 hours and 48 hours
Kansas City Cardiomyopathy Questionnaire (KCCQ)	Follow up (after 30+5 days)
Right atrial pressure (RAP)	8 hours and 48 hours

Countries

Argentina, Austria, Belgium, France, Germany, Ireland, Mexico, Philippines, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026