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 not treated with a beta-blocker. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study - S44121 vs placebo in chronic heart failure patients not on betablocker

Phase 1

• Conditions: Chronic heart failure and left ventricular dysfunction; MedDRA version: 14.1 Level: PT Classification code 10049694 Term: Left ventricular dysfunction System Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1 Level: PT Classification code 10007558 Term: Cardiac failure chronic System Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2009-011559-38-GB
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-15
• Study Completion: 2012-12-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 125

Inclusion Criteria

- Male or female patients superior or equal to 18 years and less or equal to 80 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 40 % as measured within 6 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

- Treatment with a beta-blocker within 2 months before selection.
- 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) > 480 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
<br> Primary end point(s): - Echocardiographic parameters.<br> - NT-proBNP plasma concentrations.<br> ;Main Objective: - Evaluation of the effects on cardiac function and NT-proBNP.;Secondary Objective: - Evaluation of the safety profile.