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

Phase 1

• Conditions: Chronic Heart Failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia; 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; MedDRA version: 14.1 Level: PT Classification code 10047281 Term: Ventricular arrhythmia System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-014940-12-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: 2010-03-17
• Study Completion: 2013-01-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the anti-arrhythmic efficacy of S 44121 versus placebo administered orally for a total of 12 weeks in patients with chronic heart failure (CHF) and left ventricular systolic dysfunction who received an implanted cardioverter defibrillator (ICD) for primary or secondary prevention of ventricular arrhyhthmia.;Secondary Objective: To evaluate the safety profile of S 44121.;Primary end point(s): Average rate of PVCs per hour during 48 hours Holter ECG recording.;Timepoint(s) of evaluation of this end point: Holter-based ECG parametres at the W000 (48h), and W012 (48h) visits.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Average rate of PVCs per hour during 24 hours Holter ECG recording,<br> - Occurence of individual cardiac arrhythmias as recorded on the Holter ECG,<br> - Occurence of ventricular tachycardia, ventricular fibrillation, and appropriate electrical ICD-based therapies as recorded on the ICD.<br> ;Timepoint(s) of evaluation of this end point: Holter-based ECG parameters at the W001 (24h), W004 (24h), and, ICD-based ECG parameters at W000, W012 and W014 visits.