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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Drug: Cinaciguat (BAY58-2667)
* Drug: Cinaciguat (BAY58-2667)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Cinaciguat (BAY58-2667)<br>* Infusion of 25 µg/h during 48 hours<br>|
| Experimental: Arm 2<br> | Drug: Cinaciguat (BAY58-2667)<br>* Infusion of 10 µg/h during 48 hours<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Infusion of placebo during 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Capillary Wedge Pressure |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure