Beta-Blocker Heart Attack Trial (BHAT)

NCT00000492 | Completed Phase 3

• 1 other identifier: 11
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Interventions

propranolol DRUG

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (38)

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

  BACKGROUND

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

  PMID: 7026815 BACKGROUND

• 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.

  PMID: 6120794 BACKGROUND

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

  PMID: 6120793 BACKGROUND

• 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.

  PMID: 7038157 BACKGROUND

• 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.

  PMID: 6133654 BACKGROUND

• 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.

  PMID: 6358542 BACKGROUND

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

  PMID: 6141847 BACKGROUND

• 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.

  PMID: 6851036 BACKGROUND

• Lichstein E, Morganroth J, Harrist R, Hubble E. Effect of propranolol on ventricular arrhythmia. The beta-blocker heart attack trial experience. Circulation. 1983 Jun;67(6 Pt 2):I5-10.

  PMID: 6342839 BACKGROUND

• Goldstein S. Propranolol therapy in patients with acute myocardial infarction: the Beta-Blocker Heart Attack Trial. Circulation. 1983 Jun;67(6 Pt 2):I53-7.

  PMID: 6342840 BACKGROUND

• 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.

  PMID: 6151483 BACKGROUND

• 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.

  PMID: 6148005 BACKGROUND

• 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.

  PMID: 6365352 BACKGROUND

• 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.

  PMID: 6151482 BACKGROUND

• 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.

  PMID: 3974051 BACKGROUND

• 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.

  PMID: 4045047 BACKGROUND

• 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.

  PMID: 3903736 BACKGROUND

• 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.

  PMID: 3891227 BACKGROUND

• 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.

  PMID: 4006483 BACKGROUND

• 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.

  PMID: 4053488 BACKGROUND

• 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.

  PMID: 2894282 BACKGROUND

• 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.

  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.

  PMID: 2439559 BACKGROUND

• 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.

  PMID: 3543049 BACKGROUND

• 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.

  PMID: 3555942 BACKGROUND

• 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.

  PMID: 3276112 BACKGROUND

• 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.

  PMID: 2729140 BACKGROUND

• 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.

  PMID: 2406377 BACKGROUND

• 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.

  PMID: 2188492 BACKGROUND

• Gheorghiade M, Schultz L, Tilley B, Kao W, Goldstein S. Effects of propranolol in non-Q-wave acute myocardial infarction in the beta blocker heart attack trial. Am J Cardiol. 1990 Jul 15;66(2):129-33. doi: 10.1016/0002-9149(90)90575-l.

  PMID: 2196771 BACKGROUND

• Peters RW. Propranolol and the morning increase in sudden cardiac death: (the beta-blocker heart attack trial experience). Am J Cardiol. 1990 Nov 6;66(16):57G-59G. doi: 10.1016/0002-9149(90)90398-k.

  PMID: 2239715 BACKGROUND

• Gheorghiade M, Schultz L, Tilley B, Kao W, Goldstein S. Natural history of the first non-Q wave myocardial infarction in the placebo arm of the Beta-Blocker Heart Attack Trial. Am Heart J. 1991 Dec;122(6):1548-53. doi: 10.1016/0002-8703(91)90270-r.

  PMID: 1957749 BACKGROUND

• Gheorghiade M, Shivkumar K, Schultz L, Jafri S, Tilley B, Goldstein S. Prognostic significance of electrocardiographic persistent ST depression in patients with their first myocardial infarction in the placebo arm of the Beta-Blocker Heart Attack Trial. Am Heart J. 1993 Aug;126(2):271-8. doi: 10.1016/0002-8703(93)91039-h.

  PMID: 8337995 BACKGROUND

• 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.

  PMID: 3893101 BACKGROUND

• Furberg C. The beta-blocker heart attack trial. Br J Clin Pharmacol. 1982;14 Suppl 1(Suppl 1):3S-5S. doi: 10.1111/j.1365-2125.1982.tb02053.x. No abstract available.

  PMID: 6126206 BACKGROUND

• 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.

  PMID: 6342843 BACKGROUND

• 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.

  PMID: 3510232 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Heart Arrest; Death, Sudden; Death; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Allan Barker

  Salt Lake Clinic Research Foundation

• Nemat Borhani

  University of California, Davis

• Gerald Breneman

  Henry Ford Hospital

• Frank Canosa

  Miami Heart Institute

• Robert Capone

  Rhode Island Hospital

• Richard Crow

  University of Minnesota

• Alan Forker (participated until Feb

  University of Nebraska

• Peter Gazes

  University of South Carolina

• John Gregory

  Atlantic Health System

• John Grover

  Kaiser Foundation Research Institute

• Olga Haring

  Northwestern University

• Julian Haywood

  University of Southern California

• William Holmes

  Lankenau Hospital

• Frank Ibbott

  Bio-Science Laboratories

• Robert Kohn

  State University of New York

• Robert Kramer

  Long Island Jewish-Hillside Medical Center

• Peter Kuo

  New Jersey College of Medicine and Dentistry-Rutgers

• Charles Laubach

  Geisinger Clinic

• Edgar Lichstein

  Maimonides Medical Center

• Louis Matthews

  Dartmouth-Hitchcock Medical Center

• Gordon Maurice

  Providence Medical Center

• J. McNamara

  Pacific Health Research Institute

• E. Michau

  Veterans Administration Hospital

• Richard Miller

  Baylor College of Medicine

• Joel Morganroth

  Anthropometrics Heart Clinic

• Marvin Murphy

• Robert Peters

  University of California

• Thaddeus Prout

  Greater Baltimore Medical Center

• Phillip Ranheim

  MOUNT SINAI HOSPITAL

• David Richardson

  Medical College of Virginia

• Robert Schlant

  Emory University

• James Schoenberger

  Rush-Presbyterian-St.Luke's Hospital

• Pierre Theroux

  Montreal Heart Institute

• Pantel Vokonas

  Boston University

• James Walsh

  Veterans Administration Hospital

• Gary Wilner

  Endeavor Health

• Paul Yu

  University of Rochester

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1977
• Study Completion: October 1, 1981
• Last Updated: July 12, 2016

Record last verified: 1981-10