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.

• Conditions: Chronic heart failure and left ventricular dysfunction; MedDRA version: 12.0Level: LLTClassification code 10007558Term: Cardiac failure chronic; MedDRA version: 12.0Level: LLTClassification code 10049694Term: Left ventricular dysfunction

• Registration Number: EUCTR2009-011558-16-PT
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-06
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

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

Inclusion Criteria

- Male or female patients superior or equal to 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 a 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 an 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.<br>;Secondary Objective: - Evaluation of the safety profile.;Primary end point(s): - Echocardiographic parameters.<br>- NT-proBNP plasma concentrations.