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 Servier6,505 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

6,505

Conditions

Chronic Heart Failure

Interventions

IvabradineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Number of patients having experienced the Primary Composite Endpoint.

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

Secondary Outcomes

Cardiovascular Death

Component of the primary composite endpoint

Time frame: From the date of randomization until the date of death, up to 42 months

Hospitalisation for Worsening Heart Failure

Time frame: From the date of randomization to the date of first documented hospitalisation, up to 42 months

All-cause Mortality

Time frame: From the date of randomisation to death, up to 42 months.

Death From Heart Failure

Component of cardiovascular death

Time frame: From the date of randomisation to death, up to 42 months.

Hospitalisation for Any Cause

Time frame: From the date of randomisation to the date of first documented hospitalisation, up to 42 months

Hospitalisation for Cardiovascular Reason

Time frame: From the date of randomisation to the first documented hospitalisation, up to 42 months

Unplanned Hospitalisation for Any Cause

Time frame: From the date of randomisation to the first documented hospitalisation, up to 42 months

Unplanned Hospitalisation for CV Reason

Time frame: From the date of randomisation to the first documented hospitalisation, up to 42 months.

Secondary Composite Endpoint

CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction

Time frame: From the date of randomisation to the date of the first event, up to 42 months