BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

Phase 2

Terminated

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

• Registration Number: NCT01065077
• 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: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Study Start: 2010-03
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Status Verified: 2014-11
• 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: 12

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

Primary Outcome Measures

Name	Time	Method
Pulmonary Capillary Wedge Pressure	8 hours

Secondary Outcome Measures

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