The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction
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ClinicalTrials.gov Identifier: NCT00143507 |
Recruitment Status :
Completed
First Posted : September 2, 2005
Results First Posted : June 25, 2015
Last Update Posted : April 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Disease Ventricular Dysfunction, Left | Drug: Ivabradine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10917 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Ivabradine |
Drug: Ivabradine |
Placebo Comparator: Placebo |
Drug: Placebo |
- Primary Composite Endpoint [ Time Frame: 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).
- Cardiovascular Death [ Time Frame: From the date of randomisation to death, up to 3 years. ]Cardiovascular death including sudden death of unknown cause
- Hospitalisation for Acute Myocardial Infarction [ Time Frame: 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 [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ]
- All-cause of Mortality [ Time Frame: From the date of randomisation to death, up to 3 years. ]
- Coronary Artery Disease Death [ Time Frame: From the date of randomisation to death, up to 3 years. ]Death due to heart failure, acute myocardial infarction or cardiac procedure
- Hospitalisation for Coronary Revascularisation [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ]
- Hospitalisation for Unstable Angina [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143507
United Kingdom | |
Royal Brompton National Heart and Lung Hospital | |
London, United Kingdom, SW3 6NP |
Study Chair: | Kim Fox, MD | Royal Brompton National Heart and Lung Hospital |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00143507 |
Other Study ID Numbers: |
CL3-16257-056 |
First Posted: | September 2, 2005 Key Record Dates |
Results First Posted: | June 25, 2015 |
Last Update Posted: | April 12, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies:
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Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | After Marketing Authorisation in EEA or US if the study is used for the approval. |
Access Criteria: | Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed. |
URL: | http://clinicaltrials.servier.com |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Ventricular Dysfunction Ventricular Dysfunction, Left |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |