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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Internationales Servier; Servier

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