Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study

Institut de Recherches Internationales Servier2 sites in 2 countries6,505 target enrollmentSeptember 2006

ConditionsChronic Heart Failure

InterventionsIvabradine Placebo

Overview

Phase: Phase 3
Intervention: Ivabradine
Conditions: Chronic Heart Failure
Sponsor: Institut de Recherches Internationales Servier
Enrollment: 6505
Locations: 2
Primary Endpoint: Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

April 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut de Recherches Internationales Servier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Symptomatic Chronic heart failure (NYHA II, III or IV)
•Left ventricular systolic dysfunction (LVEF ≤ 35%)
•Sinus rhythm and resting heart rate ≥ 70 bpm
•Optimal and unchanged CHF medications or dosages

Exclusion Criteria

•Unstable condition within previous 4 weeks
•Myocardial infarction or coronary revascularisation within previous 2 months
•Stroke or transient cerebral ischaemia within previous 4 weeks
•Congenital heart disease
•Severe valvular disease
•Active myocarditis
•Permanent atrial fibrillation or flutter

Arms & Interventions

Ivabradine

Intervention: Ivabradine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.

Time Frame: All over the study (up to 42 months).

Number of patients having experienced the Primary Composite Endpoint.

Secondary Outcomes

Unplanned Hospitalisation for CV Reason(From the date of randomisation to the first documented hospitalisation, up to 42 months.)
Cardiovascular Death(From the date of randomization until the date of death, up to 42 months)
Hospitalisation for Worsening Heart Failure(From the date of randomization to the date of first documented hospitalisation, up to 42 months)
All-cause Mortality(From the date of randomisation to death, up to 42 months.)
Death From Heart Failure(From the date of randomisation to death, up to 42 months.)
Hospitalisation for Any Cause(From the date of randomisation to the date of first documented hospitalisation, up to 42 months)
Hospitalisation for Cardiovascular Reason(From the date of randomisation to the first documented hospitalisation, up to 42 months)
Unplanned Hospitalisation for Any Cause(From the date of randomisation to the first documented hospitalisation, up to 42 months)
Secondary Composite Endpoint(From the date of randomisation to the date of the first event, up to 42 months)