Conditions: Chronic Heart Failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6505
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ivabradine intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months. intervention 2: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.

Protocol document: