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

This study has been completed.

Sponsor:

Information provided by:

Servier

ClinicalTrials.gov Identifier:

NCT00143507

First received: August 31, 2005

Last updated: June 15, 2011

Last verified: June 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Coronary Disease Ventricular Dysfunction, Left	Drug: Ivabradine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
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.

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Servier:

Primary Outcome Measures:

Composite endpoint including cardiovascular mortality, hospitalisation for acute myocardial infarction and for new onset or worsening heart failure.

Secondary Outcome Measures:

Composite and non-composite endpoints including hospitalisation for acute coronary syndrome, coronary revascularisation and mortality.


Estimated Enrollment:	10000
Study Start Date:	December 2004
Study Completion Date:	February 2008

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143507

Locations


United Kingdom
Royal Brompton National Heart and Lung Hospital
London, United Kingdom, SW3 6NP

Sponsors and Collaborators

Institut de Recherches Internationales Servier

Investigators


Study Chair:	Kim Fox, MD	Royal Brompton National Heart and Lung Hospital

More Information

No publications provided by Servier

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.


ClinicalTrials.gov Identifier:	NCT00143507 History of Changes
Other Study ID Numbers:	CL3-16257-056
Study First Received:	August 31, 2005
Last Updated:	June 15, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:


Coronary Artery Disease Coronary Disease Myocardial Ischemia Ventricular Dysfunction Ventricular Dysfunction, Left	Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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