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)

Phase 2

Terminated

• Conditions: Heart Failure; Heart Decompensation
• Interventions: Drug: Cinaciguat (BAY58-2667); Drug: Placebo

• Registration Number: NCT01064037
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Study Start: 2010-04
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2014-10
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-08
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Cinaciguat (BAY58-2667)	-
Arm 3	Cinaciguat (BAY58-2667)	-
Arm 1	Cinaciguat (BAY58-2667)	-
Arm 4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Dyspnea VAS (using a visual analogue scale)	8 hours

Secondary Outcome Measures

Name	Time	Method
Overall health status assessment (EQ-5D)	up to follow-up (30 - 35 days)
Global clinical assessment by the physician	At 8, 24, and 48 hours
Overall health status assessment through EQ-5D Health Questionnaire	Up to the follow-up visit
Safety variables	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
Changes in the dyspnea VAS at other time points	Up to follow up visit
Change in concomitant medications	During the treatment
Dyspnea assessment (Likert Scale)	up to follow-up (30 - 35 days)
Dyspnea assessment through Likert scale	Up to follow up visit