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ArrhythmiaPhase 3NCT00000492

Beta-Blocker Heart Attack Trial (BHAT)

A Phase 3 study testing propranolol in people with Arrhythmia and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 69 years
What is being tested?
propranolol
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1977to Oct 1981
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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.

Read the 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).

Being tested
propranolol
Medical subject headings
Arrhythmias, Cardiac, Cardiovascular Diseases, Coronary Disease, Death, Sudden, Cardiac, Heart Diseases, Myocardial Infarction, Myocardial Ischemia, Ventricular Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • propranololDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startSep 1977
  3. Study completionOct 1981

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000492
Sponsor's protocol ID
11
Status last verified
Oct 1981
First submitted
27 Oct 1999
Last updated
12 Jul 2016
Results posted
No

Publications

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

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

    PubMed 7026815

  • 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.

    PubMed 6120794

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

    PubMed 6120793

  • 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.

    PubMed 7038157

  • 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.

    PubMed 6133654

  • 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.

    PubMed 6358542

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

    PubMed 6141847

  • 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.

    PubMed 6851036

  • 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.

    PubMed 6342839

  • 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.

    PubMed 6342840

  • 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.

    PubMed 6151483

  • 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.

    PubMed 6148005

  • 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.

    PubMed 6365352

  • 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.

    PubMed 6151482

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing propranolol in people with Arrhythmia and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000492, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.

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