NCT02441218

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,505 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	Ivabradine	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.
DRUG	Placebo	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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2015-05-12
• Last updated: 2020-01-03
• Results posted: 2015-06-29

Locations

2 sites across 2 countries: France, Sweden