Beta-Blocker Heart Attack Trial (BHAT)

NCT ID: NCT00000492

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1977-09-30
• Study Completion Date: 1981-10-31

Brief Summary

To determine whether the regular administration of the beta-blocker drug propranolol to people who had had at least one documented myocardial infarction would result in a significant reduction of mortality from all causes over the follow-up period. Eligible volunteer patients were recruited to participate in a double-blind clinical trial within 21 days after the onset of the acute event. One-half of the patients were randomly assigned to a beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons with documented previous myocardial infarction.

Detailed Description

BACKGROUND:

Survivors of a documented myocardial infarction are recognized as having a high risk of dying relative to the general population. Serious arrhythmias, occurring with or without evidence of new infarction, are a common cause of death in this population. Theoretically, an agent which (1) can block the sympathetic nervous activity thought to be involved in precipitating sudden death and (2) has non-neurogenic antiarrhythmic properties would be of value to people with coronary heart disease. Propranolol, like other beta- blocking agents, has these as well as other properties and therefore might be expected to prevent or retard complications of coronary heart disease such as serious arrhythmias. This would be reflected in a decrease in mortality due to coronary heart disease.

A workshop on chronic antiarrhythmic therapy reviewed contemporary experimental data and clinical practice and recommended that a clinical trial be undertaken to clearly show the effects of beta-blocking drugs on mortality. Subsequently, such a trial was approved by the Clinical Applications and Prevention Advisory Committee, by the Cardiology Advisory Committee, and by the National Heart, Lung, and Blood Advisory Council.

The study protocol was reviewed in February 1978 and recommended for approval by the policy-data monitoring board and ad hoc members. The protocol was approved by the Director of NHLBI in March 1978. Recruitment started on June 19, 1978, and ended in October 1980. A total of 3,837 patients were randomized. Units which participated in the trial included 32 clinical centers, an EKG center, a central laboratory, a coordinating center, a 1-hour ambulatory ECG center, a 24-hour ambulatory EKG center, and an EKG tape quality control center.

DESIGN NARRATIVE:

A randomized, double-blind design with single experimental and control groups. Patients were recruited while in the hospital for an acute myocardial infarction and were enrolled in the study before discharge. Eligible patients fulfilled the study definition of an acute myocardial infarction. The diagnosis was based either on electrocardiographic records showing evolving QRS segment changes or on ST segment and T wave changes together with enzyme changes and appropriate clinical history. One-half of the patients were placed on therapy using a beta-blocking drug (propranolol). The other half received a placebo. The prescribed maintenance dosage of propranolol was either l80 or 240 mgs/day, depending upon serum drug levels. Intervention duration averaged 25 months.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Conditions

Arrhythmia; Cardiovascular Diseases; Coronary Disease; Death, Sudden, Cardiac; Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Ventricular Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

propranolol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Men and women, ages 30 to 69. Documented myocardial infarction.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Allan Barker

Role:

Salt Lake Clinic Research Foundation

Nemat Borhani

Role:

University of California, Davis

Gerald Breneman

Role:

Henry Ford Hospital

Frank Canosa

Role:

Miami Heart Institute

Robert Capone

Role:

Rhode Island Hospital

Richard Crow

Role:

University of Minnesota

Alan Forker (participated until Feb

Role:

University of Nebraska

Peter Gazes

Role:

University of South Carolina

John Gregory

Role:

Atlantic Health System

John Grover

Role:

Kaiser Foundation Research Institute

Olga Haring

Role:

Northwestern University

Julian Haywood

Role:

University of Southern California

William Holmes

Role:

Lankenau Hospital

Frank Ibbott

Role:

Bio-Science Laboratories

Robert Kohn

Role:

State University of New York

Robert Kramer

Role:

Long Island Jewish-Hillside Medical Center

Peter Kuo

Role:

New Jersey College of Medicine and Dentistry-Rutgers

Charles Laubach

Role:

Geisinger Clinic

Edgar Lichstein

Role:

Maimonides Medical Center

Louis Matthews

Role:

Dartmouth-Hitchcock Medical Center

Gordon Maurice

Role:

Providence Medical Center

J. McNamara

Role:

Pacific Health Research Institute

E. Michau

Role:

Veterans Administration Hospital

Richard Miller

Role:

Baylor College of Medicine

Joel Morganroth

Role:

Anthropometrics Heart Clinic

Marvin Murphy

Role:

Robert Peters

Role:

University of California

Thaddeus Prout

Role:

Greater Baltimore Medical Center

Phillip Ranheim

Role:

MOUNT SINAI HOSPITAL

David Richardson

Role:

Medical College of Virginia

Robert Schlant

Role:

Emory University

James Schoenberger

Role:

Rush-Presbyterian-St.Luke's Hospital

Pierre Theroux

Role:

Montreal Heart Institute

Pantel Vokonas

Role:

Boston University

James Walsh

Role:

Veterans Administration Hospital

Gary Wilner

Role:

Endeavor Health

Paul Yu

Role:

University of Rochester

References

Beta-Blocker Heart Attack Trial Study Group: Beta-Blocker Heart Attack Trial Study Protocol. DHHS Pub. No. (NIH)81-2209, 1980.

Reference Type: BACKGROUND

The beta-blocker heart attack trial. beta-Blocker Heart Attack Study Group. JAMA. 1981 Nov 6;246(18):2073-4.

Reference Type: BACKGROUND

PMID: 7026815 (View on PubMed)

Howard JM, DeMets D. How informed is informed consent? The BHAT experience. Control Clin Trials. 1981 Dec;2(4):287-303. doi: 10.1016/0197-2456(81)90019-2.

Reference Type: BACKGROUND

PMID: 6120794 (View on PubMed)

Beta Blocker Heart Attack Trial: design features. Control Clin Trials. 1981 Dec;2(4):275-85. doi: 10.1016/0197-2456(81)90018-0.

Reference Type: BACKGROUND

PMID: 6120793 (View on PubMed)

A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA. 1982 Mar 26;247(12):1707-14. doi: 10.1001/jama.1982.03320370021023.

Reference Type: BACKGROUND

PMID: 7038157 (View on PubMed)

Furberg CD, Byington RP. What do subgroup analyses reveal about differential response to beta-blocker therapy? The Beta-Blocker Heart Attack Trial experience. Circulation. 1983 Jun;67(6 Pt 2):I98-101.

Reference Type: BACKGROUND

PMID: 6133654 (View on PubMed)

A randomized trial of propranolol in patients with acute myocardial infarction. II. Morbidity results. JAMA. 1983 Nov 25;250(20):2814-9. doi: 10.1001/jama.1983.03340200048027.

Reference Type: BACKGROUND

PMID: 6358542 (View on PubMed)

Goldstein S. The Beta-Blocker Heart Attack Trial in perspective. Cardiology. 1983;70(5):255-62. doi: 10.1159/000173602.

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PMID: 6141847 (View on PubMed)

Shulman RS, Herbert PN, Capone RJ, McClure D, Hawkins CM, Henderson LO, Saritelli A, Campbell J. Effects of propranolol on blood lipids and lipoproteins in myocardial infarction. Circulation. 1983 Jun;67(6 Pt 2):I19-21.

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PMID: 6342840 (View on PubMed)

Byington RP. Beta-blocker heart attack trial: design, methods, and baseline results. Beta-blocker heart attack trial research group. Control Clin Trials. 1984 Dec;5(4):382-437. doi: 10.1016/s0197-2456(84)80017-3.

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PMID: 6151483 (View on PubMed)

Haywood LJ. Coronary heart disease mortality/morbidity and risk in blacks. I: Clinical manifestations and diagnostic criteria: the experience with the Beta Blocker Heart Attack Trial. Am Heart J. 1984 Sep;108(3 Pt 2):787-93. doi: 10.1016/0002-8703(84)90672-0.

Reference Type: BACKGROUND

PMID: 6148005 (View on PubMed)

Furberg CD, Hawkins CM, Lichstein E. Effect of propranolol in postinfarction patients with mechanical or electrical complications. Circulation. 1984 Apr;69(4):761-5. doi: 10.1161/01.cir.69.4.761.

Reference Type: BACKGROUND

PMID: 6365352 (View on PubMed)

DeMets DL, Hardy R, Friedman LM, Lan KK. Statistical aspects of early termination in the beta-blocker heart attack trial. Control Clin Trials. 1984 Dec;5(4):362-72. doi: 10.1016/s0197-2456(84)80015-x.

Reference Type: BACKGROUND

PMID: 6151482 (View on PubMed)

Byington RP, Curb JD, Mattson ME. Assessment of double-blindness at the conclusion of the beta-Blocker Heart Attack Trial. JAMA. 1985 Mar 22-29;253(12):1733-6.

Reference Type: BACKGROUND

PMID: 3974051 (View on PubMed)

Byington R, Goldstein S. Association of digitalis therapy with mortality in survivors of acute myocardial infarction: observations in the Beta-Blocker Heart Attack Trial. J Am Coll Cardiol. 1985 Nov;6(5):976-82. doi: 10.1016/s0735-1097(85)80297-7.

Reference Type: BACKGROUND

PMID: 4045047 (View on PubMed)

Morganroth J, Lichstein E, Byington R. Beta-Blocker Heart Attack Trial: impact of propranolol therapy on ventricular arrhythmias. Prev Med. 1985 May;14(3):346-57. doi: 10.1016/0091-7435(85)90061-1.

Reference Type: BACKGROUND

PMID: 3903736 (View on PubMed)

Bell RL, Curb JD, Friedman LM, McIntyre KM, Payton-Ross C. Enhancement of visit adherence in the national beta-blocker heart attack trial. Control Clin Trials. 1985 Jun;6(2):89-101. doi: 10.1016/0197-2456(85)90114-x.

Reference Type: BACKGROUND

PMID: 3891227 (View on PubMed)

Bell RL, Curb JD, Friedman LM, Payne GH. Termination of clinical trials: the beta-blocker heart attack trial and the hypertension detection and follow-up program experience. Control Clin Trials. 1985 Jun;6(2):102-11. doi: 10.1016/0197-2456(85)90115-1.

Reference Type: BACKGROUND

PMID: 4006483 (View on PubMed)

Walle T, Byington RP, Furberg CD, McIntyre KM, Vokonas PS. Biologic determinants of propranolol disposition: results from 1308 patients in the Beta-Blocker Heart Attack Trial. Clin Pharmacol Ther. 1985 Nov;38(5):509-18. doi: 10.1038/clpt.1985.216.

Reference Type: BACKGROUND

PMID: 4053488 (View on PubMed)

Goldstein S, Byington R. The Beta Blocker Heart Attack Trial: recruitment experience. Control Clin Trials. 1987 Dec;8(4 Suppl):79S-85S. doi: 10.1016/0197-2456(87)90010-9.

Reference Type: BACKGROUND

PMID: 2894282 (View on PubMed)

Furberg CD, Friedman LM, MacMahon SW: Women as Participants in Trials of the Primary and Secondary Prevention of Cardiovascular Disease: Part II. Secondary Prevention: The Beta-Blocker Heart Attack Trial and the Aspirin Myocardial Infarction Study, in: Coronary Heart Disease in Women. Ed Eaker, B Packard, NK Wenger, TB Clarkson, HA Tyroler (Eds). New York, Haymarket Doyma, pp 241-246, 1987.

Reference Type: BACKGROUND

Kostis JB, Byington R, Friedman LM, Goldstein S, Furberg C. Prognostic significance of ventricular ectopic activity in survivors of acute myocardial infarction. J Am Coll Cardiol. 1987 Aug;10(2):231-42. doi: 10.1016/s0735-1097(87)80001-3.

Reference Type: BACKGROUND

PMID: 2439559 (View on PubMed)

Peters RW, Byington R, Arensberg D, Friedman LM, Romhilt DW, Barker A, Laubach C, Wilner GW, Goldstein S. Mortality in the beta blocker heart attack trial: circumstances surrounding death. J Chronic Dis. 1987;40(1):75-82. doi: 10.1016/0021-9681(87)90098-1.

Reference Type: BACKGROUND

PMID: 3543049 (View on PubMed)

Davis BR, Furberg CD, Williams CB. Survival analysis of adverse effects data in the Beta-Blocker Heart Attack Trial. Clin Pharmacol Ther. 1987 Jun;41(6):611-5. doi: 10.1038/clpt.1987.83.

Reference Type: BACKGROUND

PMID: 3555942 (View on PubMed)

Davis BR, Friedman LM, Lichstein E. Are 24 hours of ambulatory ECG monitoring necessary for a patient after infarction? Am Heart J. 1988 Jan;115(1 Pt 1):83-91. doi: 10.1016/0002-8703(88)90521-2.

Reference Type: BACKGROUND

PMID: 3276112 (View on PubMed)

Peters RW, Muller JE, Goldstein S, Byington R, Friedman LM. Propranolol and the morning increase in the frequency of sudden cardiac death (BHAT Study). Am J Cardiol. 1989 Jun 15;63(20):1518-20. doi: 10.1016/0002-9149(89)90019-2. No abstract available.

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Peters RW, Byington RP, Barker A, Yusuf S. Prognostic value of prolonged ventricular repolarization following myocardial infarction: the BHAT experience. The BHAT Study Group. J Clin Epidemiol. 1990;43(2):167-72. doi: 10.1016/0895-4356(90)90180-w.

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Byington RP, Worthy J, Craven T, Furberg CD. Propranolol-induced lipid changes and their prognostic significance after a myocardial infarction: the Beta-Blocker Heart Attack Trial experience. Am J Cardiol. 1990 Jun 1;65(20):1287-91. doi: 10.1016/0002-9149(90)91314-v.

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PMID: 1957749 (View on PubMed)

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Friedman LM, Byington RP. Assessment of angina pectoris after myocardial infarction: comparison of "Rose Questionnaire" with physician judgment in the Beta-Blocker Heart Attack Trial. Am J Epidemiol. 1985 Apr;121(4):555-62. doi: 10.1093/oxfordjournals.aje.a114033.

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Hawkins CM, Richardson DW, Vokonas PS. Effect of propranolol in reducing mortality in older myocardial infarction patients. The Beta-Blocker Heart Attack Trial experience. Circulation. 1983 Jun;67(6 Pt 2):I94-7.

Reference Type: BACKGROUND

PMID: 6342843 (View on PubMed)

Friedman LM, Byington RP, Capone RJ, Furberg CD, Goldstein S, Lichstein E. Effect of propranolol in patients with myocardial infarction and ventricular arrhythmia. J Am Coll Cardiol. 1986 Jan;7(1):1-8. doi: 10.1016/s0735-1097(86)80250-9.

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Study Documents

Document Type: Individual Participant Data Set

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Document Type: Study Forms

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Other Identifiers

11

Identifier Type: -

Identifier Source: org_study_id