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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000708-18-SE
Enrollment
5500
Registered
2006-08-01
Start date
2006-08-23
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

cardiac failure chronic MedDRA version: 9.0 Level: PT Classification code 10007558

Interventions

Product Name: S16257 Product Code: S16257 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257 Concentration unit: mg milligram(

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - unstable cardiovascular condition - recent myocardial infarction or coronary revascularisation - congenital heart diseases - severe valvular disease - active myocarditis

Design outcomes

Primary

MeasureTime frame
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—

Countries

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Portugal, Slovenia, Spain, Sweden, United Kingdom

Outcome results

None listed

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