Evaluation of the anti-arrhythmic effects of 3 dosages of S 44121 versus placebo in patients with chronic heart failure at risk for ventricular arrhythmia
Phase 2
Completed
- Conditions
- Cardiac arrhythmia in chronic heart failureCirculatory SystemOther cardiac arrhythmias
- Registration Number
- ISRCTN14227980
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 149
Inclusion Criteria
1. Both genders patients between 18 years or legal age and 80 years
2. Symptomatic chronic heart failure for at least 6 months
3. Ischaemic disease or idiopathic dilated cardiomyopathy as main cause for chronic heart failure
Exclusion Criteria
1. Women who are pregnant, breast-feeding or not using contraception
2. Recent myocardial infarction, unstable angina or coronary revascularisation less than 3 months before selection
3. History of stroke or cerebral transient ischemic attack within the previous 3 months before selection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy measurements recorded on the Holter ECG, measured at at inclusion visit and 1 week, 4 weeks and 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method <br> 1. Safety profile measured by 12-lead resting ECG, measured at each visit<br> 2. Physical examination, measured at each visit<br> 3. Adverse events, recorded throughout the study<br> 4. Blood clinical laboratory parameters, measured at at inclusion visit and after 12 weeks of treatment<br>