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)

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 BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

Conditions
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Heart Failure, Heart Decompensation

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

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 150 µg/h during 48h.<br>|
| Experimental: Arm 2<br> | Drug: Cinaciguat (BAY58-2667)<br>* Infusion of 100 µg/h during 48h<br>|
| Experimental: Arm 3<br> | Drug: Cinaciguat (BAY58-2667)<br>* Infusion of 50 µg/h during 48h<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Infusion during 48h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea VAS (using a visual analogue scale) |  | 8 hours | 

Secondary Outcome Measures

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

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