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
- cardiac failure chronicMedDRA version: 9.0Level: PTClassification code 10007558
- Registration Number
- EUCTR2006-000708-18-DE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6500
Inclusion Criteria
- male or female patients >= 18 years
- Chronic Heart Failure
- left ventricular systolic dysfunction
- sinus 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 hospitalisations (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