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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-year Randomised Double-blind Placebo-controlled International Multicentre Study.

Conditions
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Coronary Disease, Ventricular Dysfunction, Left

Intervention / Treatment
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* Drug: Ivabradine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivabradine<br> | Drug: Ivabradine<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Composite Endpoint | 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). | From the date of randomisation to the date of the first occurrence of the first event, up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Death | Cardiovascular death including sudden death of unknown cause | From the date of randomisation to death, 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. | 
| All-cause of Mortality |  | From the date of randomisation to death, up to 3 years. | 
| Coronary Artery Disease Death | Death due to heart failure, acute myocardial infarction or cardiac procedure | From the date of randomisation to death, up to 3 years. | 
| Hospitalisation for Coronary Revascularisation |  | From the date of randomisation to the date of first occurrence of the event, up to 3 years. | 
| Hospitalisation for Unstable Angina |  | From the date of randomisation to the date of first occurrence of the event, 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. | 
| 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, 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. | 
| 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. |