Effects of Ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction. A three-year randomised double blind placebo controlled international multicentre study - SHIFT
- Conditions
- Chronic heart failureMedDRA version: 9.1Level: LLTClassification code 10007558Term: Cardiac failure chronic
- Registration Number
- EUCTR2006-000708-18-IT
- Lead Sponsor
- INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5500
Inclusion Criteria
Male or female patients 18 years; chronic heart failure;left ventricular systolic disfunction and synus rythm
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
Unstable cardiovascular condition; recent myocardial infarction or coronary revascularisation;congenital heart diseases;severe valvular disease;active myocarditis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of Ivabradine on the reduction of cardiovascular mortality and hospitalisations for worsening heart failure;Secondary Objective: To assess the effects of Ivabradine on the reduction in mortality and hospitalisation all causes and on symptoms of heart failure.;Primary end point(s): Composite endpoint made of cardiovascular death or hospitalisation for worsening heart failure
- Secondary Outcome Measures
Name Time Method