Beta-Blocker Heart Attack Trial (BHAT)
Clinical Trials URL:
Study Type: Clinical Trial
Prepared on October 13, 2008
Last Updated on June 23, 2005
Study Dates: 1977-1981
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DCVS
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information
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.
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.
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.
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).