Evaluation of the anti-arrhythmic effects of 3 oral dosages of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014940-12-FR

Enrollment

160

Registered

2010-01-22

Start date

2010-03-11

Completion date

Unknown

Last updated

2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia MedDRA version: 12.1 Level: LLT Classification code 10007558 Term: Cardiac failure chronic MedDRA version: 12.1 Level: LLT Classification code 10049694 Term: Left ventricular dysfunction MedDRA version: 12.1 Level: LLT Classification code 10047281 Term: Ventricular arrhythmia

Interventions

Product Name: S44121 Product Code: S44121 Pharmaceutical Form: Granules for oral suspension Current Sponsor code: S44121 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female patients. - Aged between 18 and 75 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 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 rhythm. 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

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 6 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Belgium, Czech Republic, France, Germany, Hungary, Portugal, Slovakia, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026