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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ivabradine

Group Type EXPERIMENTAL

Ivabradine

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No