The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction

Phase 3

Completed

• Conditions: Coronary Disease; Ventricular Dysfunction, Left
• Interventions: Drug: Ivabradine; Drug: Placebo

• Registration Number: NCT00143507
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2015-05-13
• Results First Submitted QC: 2015-06-22
• Results First Posted: 2015-06-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10917

Inclusion Criteria

• Coronary artery disease
• Left ventricular systolic dysfunction
• Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)

Exclusion Criteria

• Unstable cardiovascular condition
• Severe congestive heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivabradine	Ivabradine	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Primary Composite Endpoint	From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.	First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).

Secondary Outcome Measures

Name	Time	Method
Hospitalisation for Unstable Angina	From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Coronary Artery Disease Death	From the date of randomisation to death, up to 3 years.	Death due to heart failure, acute myocardial infarction or cardiac procedure
All-cause of Mortality	From the date of randomisation to death, up to 3 years.
Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)	From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure	From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Hospitalisation for Acute Myocardial Infarction	From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for New Onset or Worsening Heart Failure	From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation	From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation	From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Cardiovascular Death	From the date of randomisation to death, up to 3 years.	Cardiovascular death including sudden death of unknown cause
Hospitalisation for Coronary Revascularisation	From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction	From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

Trial Locations

Locations (1)

Royal Brompton National Heart and Lung Hospital; 🇬🇧 London, United Kingdom