The Beta-Blocker Heart Attack Trial (BHAT)
Objectives:
The Beta-Blocker Heart Attack Trial (BHAT) was a
National Heart, Lung, and Blood Institute-sponsored, multicenter, randomized,
double-blind, and placebo-controlled trial designed to test whether the regular
administration of propranolol hydrochloride to men and women who had
experienced at least one myocardial infarction would result in a significant
reduction in total mortality during a two- to four-year period.
Background:
By the mid 1970s, beta-blocking agents were commonly
used in the treatment of coronary heart disease, primarily for the symptomatic
releif of angina pectoris. Because of indications that beta-blockers would be
beneficial, a number of clinical trials were carried out. Several of these
studies showed trends favoring the use of beta-blockers, however because of
small sample size and other limitations in design and analysis, the results
were inconclusive. Based on these studies, the NHLBI decided that a study of
sufficient size would be needed to address the question of the benefits of
beta-blockers.
Subjects:
During a 27-month interval, 3,837 persons between the
ages of 30 and 69 years were randomized to either propranolol (1,916 persons)
or placebo (1,912 persons), five to 21 days after the infarction. Depending on
serum drug levels, the prescribed maintenance dose of propranolol hydrochloride
was either 180 or 240 mg/day. The trial was stopped nine months ahead of
schedule.
Conclusions:
Total mortality during the average 24-month follow-up
period was 7.2% in the propranolol group and 9.8% in the placebo group.
Arteriosclerotic heart disease (ASHD) mortality was 6.2% in the propranolol
group and 8.5% in the placebo group. Sudden cardiac death, a subset of ASHD
mortality, was 3.3% among the propranolol patients and 4.6% among the placebo
patients. Serious side effects were uncommon. Hypotension, gastrointestinal
problems, tiredness, bronchospasm, and cold hands and feet occurred more
frequently in the propranolol group. Based on the BHAT results, the use of
propranolol in patients with no contraindications to beta-blockade who have had
a recent myocardial infarction is recommended for at least three years (JAMA
1982;247:1707-1714).
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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