Evaluation of the effects of 4 oral dosages of S 44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction. A 12 week, randomized, double-blind, parallel group, placebo controlled, international multicentre study. - ND

• Conditions: Chronic heart failure and left ventricular dysfunction; MedDRA version: 9.1Level: LLTClassification code 10007558; MedDRA version: 9.1Level: LLTClassification code 10049694

• Registration Number: EUCTR2009-011558-16-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-25
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Male or female patients superior or equal 18 years and less or equal to 75 years. - Symptomatic chronic heart failure for at least 6 months before selection. - NYHA functional class II or III. - Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF. - Left ventricular systolic dysfunction as evidenced by LVEF less or equal to 35% as measured within 6 months before selection. - Beta-blocker treatment for at least 3 months before selection. - ACE inhibitor and/or ARB treatment for at least 3 months before selection. - NT-proBNP plasma concentration superior or equal to 400 pg/mL or BNP plasma concentration superior or equal to 100 pg/mL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unstable condition within the previous 4 weeks before selection. - Recent (less than 3 months before selection) myocardial infarction, unstable angina or coronary revascularisation. - History of stroke or cerebral transient ischemic attack within the previous 3 months before selection. - Severe aortic or mitral stenosis, severe aortic regurgitation, or severe mitral regurgitation. - Congenital heart disease. - Hypertrophic obstructive cardiomyopathy. - Pericardial disease. - Atrio-ventricular block of second or third degree. - Corrected QT interval duration (Bazett s formula) > 450 ms. - Family history of long QT syndrome or congenital long QT syndrome. - Serum creatinine > 200 micromoles/L (> 2.26 mg/dL). - ALAT or ASAT > 3 times the upper limit of normal values. - Serum total calcium < 2.1 mmol/L or > 2.6 mmol/L. - Blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the effects on cardiac function and NT-proBNP;Secondary Objective: Evaluation of the safety profile;Primary end point(s): Echocardiographic parameters. - NT-proBNP plasma concentrations.