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Trial NCT00000560

Resource URI: http://static.linkedct.org/resource/trials/NCT00000560
linkedct:brief_title Beta-Blocker Evaluation in Survival Trial (BEST)
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/5704>
linkedct:condition <http://static.linkedct.org/resource/condition/5709>
linkedct:criteria Men and women, ages 18 and over. Patients had compensated congestive heart failure due to idiopathic dilated cardiomyopathy or coronary disease with ejection fraction less than or equal to 0.35, were in the New York Heart Association functional class III or IV, and were taking an angiotensin-converting enzyme inhibitor, digitalis, and if needed, a diuretic. Patients with a specific indication for, or contraindication to, beta-blockade were excluded.
linkedct:description BACKGROUND: Controlled and uncontrolled studies suggested that beta-blockade improves ventricular function in congestive heart failure. Several trials suggested that beta-blockers may also reduce mortality. In the Beta-Blocker Heart Attack Trial, patients with a history of heart failure had less cardiac and sudden-death mortality than those who did not. Patients with a low ejection fraction in the Cardiac Arrhythmia Suppression Trial who were treated with beta-blockade also had a reduction in mortality. The Metoprolol in Dilated Cardiomyopathy trial randomized patients with dilated cardiomyopathies to treatment with metoprolol or placebo. There was a trend toward reduction in a morbidity and mortality endpoint in patients treated with metoprolol, but this was due entirely to a reduction in the need for cardiac transplantation. Thus, despite a reasonable theoretical basis and suggestive clinical studies, the concept that beta-blockers reduced mortality in congestive heart failure patients was unproved. DESIGN NARRATIVE: Randomized, double-blind, multicenter. Patients were assigned to standard therapy plus the addition of a beta-blocker (bucindolol) versus a placebo. The primary endpoint was total mortality. A radionuclide ventriculogram was performed within 60 days of randomization. History, physical examination, clinical laboratory studies, chest x-ray, electrocardiogram, and plasma norepinephrine levels were obtained within 14 days of randomization. Patients were stratified by hospital, congestive heart failure etiology, ejection fraction, and gender, and were assigned to a treatment group by an adaptive balancing scheme ("biased coin" randomization). Patients were randomized to either placebo plus standard congestive heart failure treatment or to the beta-blocker plus standard congestive heart failure treatment and followed for a minimum of 18 months. The over three year recruitment period began in May 1995 at the first 35 sites. An additional 55 sites began recruitment on August 14, 1995. Recruitment ended in December, 1998 with the enrollment of 2,708 patients.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 1999
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000560
rdfs:label Trial NCT00000560
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000560
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 104
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/47217>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000560>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/10317>
linkedct:reference <http://static.linkedct.org/resource/reference/13612>
linkedct:reference <http://static.linkedct.org/resource/reference/18620>
linkedct:reference <http://static.linkedct.org/resource/reference/18965>
linkedct:reference <http://static.linkedct.org/resource/reference/19449>
linkedct:reference <http://static.linkedct.org/resource/reference/19854>
linkedct:reference <http://static.linkedct.org/resource/reference/20408>
linkedct:reference <http://static.linkedct.org/resource/reference/23559>
linkedct:reference <http://static.linkedct.org/resource/reference/25717>
linkedct:reference <http://static.linkedct.org/resource/reference/26310>
linkedct:reference <http://static.linkedct.org/resource/reference/46111>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date June 1994
linkedct:study_design Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To determine if addition of a beta-blocker to standard therapy in Class III and Class IV heart failure patients reduced total mortality.
rdf:type linkedct:trials
linkedct:verification_date April 2005