Evaluation of the antiarrhythmic effects of 3 dosages of S 44121 versus placebo in patients with chronic heart failure at risk for ventricular arrhythmia.

• Conditions: Chronic Heart Failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia; MedDRA version: 14.1Level: PTClassification code 10007558Term: Cardiac failure chronicSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 14.1Level: PTClassification code 10047281Term: Ventricular arrhythmiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10049694Term: Left ventricular dysfunctionSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2009-014940-12-DE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-28
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- Male or female patients.
- Aged between 18 and 80 years (inclusive).
- ICD for primary or secondary prevention of ventricular arrhythmia for at least 3 months before selection.
- Symptomatic CHF for at least 6 months before selection.
- NYHA functional class I, II or III.
- Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF.
- Treatment with a beta-blocker for at least 3 months before selection.
- An average number of at least 100 premature ventricular complexes (PVCs) per hour on a 48-hour Holter ECG recording.
- LVEF = 40% at echocardiographic examination.
- Sinus or atrial rhythm (paced or spontaneous).
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

- Unstable condition within 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 3 months before selection.
- Severe primary aortic or mitral stenosis or regurgitation.
- Congenital heart disease.
- Hypertrophic obstructive cardiomyopathy.
- Cardiac resynchronisation therapy (CRT) started within 3 months before selection.
- Episode of reverted ventricular fibrillation or Torsade de Pointes within 4 weeks before selection.
- Atrio-ventricular block of second or third degree.
- Corrected QT interval duration (Bazett’s formula) > 480 ms.

Study & Design

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