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

Phase 3

Completed

• Conditions: Chronic Heart Failure
• Interventions: Drug: Placebo; Drug: Ivabradine

• Registration Number: NCT02441218
• Lead Sponsor: Institut de Recherches Internationales Servier

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

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Results First Submitted: 2015-05-12
• Results First Submitted QC: 2015-06-22
• Results First Posted: 2015-06-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6505

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ivabradine	Ivabradine	-

Primary Outcome Measures

Name	Time	Method
Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.	All over the study (up to 42 months).	Number of patients having experienced the Primary Composite Endpoint.

Secondary Outcome Measures

Name	Time	Method
Unplanned Hospitalisation for CV Reason	From the date of randomisation to the first documented hospitalisation, up to 42 months.
Cardiovascular Death	From the date of randomization until the date of death, up to 42 months	Component of the primary composite endpoint
Hospitalisation for Worsening Heart Failure	From the date of randomization to the date of first documented hospitalisation, up to 42 months
All-cause Mortality	From the date of randomisation to death, up to 42 months.
Death From Heart Failure	From the date of randomisation to death, up to 42 months.	Component of cardiovascular death
Hospitalisation for Any Cause	From the date of randomisation to the date of first documented hospitalisation, up to 42 months
Hospitalisation for Cardiovascular Reason	From the date of randomisation to the first documented hospitalisation, up to 42 months
Unplanned Hospitalisation for Any Cause	From the date of randomisation to the first documented hospitalisation, up to 42 months
Secondary Composite Endpoint	From the date of randomisation to the date of the first event, up to 42 months	CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction

Trial Locations

Locations (2)

Göteborg University; 🇸🇪 Göteborg, Sweden

Hôpital Pitié-Salpétrière; 🇫🇷 Paris, France