Beta-Blocker Heart Attack Trial (BHAT)

July 11, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Allan Barker, Salt Lake Clinic Research Foundation
  • Nemat Borhani, University of California, Davis
  • Olga Haring, Northwestern University
  • J. McNamara, Pacific Health Research Institute
  • Thaddeus Prout, Greater Baltimore Medical Center
  • Robert Schlant, Emory University
  • Gary Wilner, Northshore University Healthsystem
  • Robert Capone, Rhode Island Hospital
  • David Richardson, Medical College of Virginia
  • Pierre Theroux, Montreal Heart Institute
  • Frank Ibbott, Bio-Science Laboratories
  • Gerald Breneman, Henry Ford Hospital
  • Frank Canosa, Miami Heart Institute
  • 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
  • Julian Haywood, University of Southern California
  • William Holmes, Lankenau Hospital
  • 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
  • E. Michau, Veterans Administration Hospital
  • Richard Miller, Baylor College of Medicine
  • Joel Morganroth, Anthropometrics Heart Clinic
  • Marvin Murphy
  • Robert Peters, University of California
  • Phillip Ranheim, Mount Sinai Hospital
  • James Schoenberger, Rush-Presbyterian-St.Luke's Hospital
  • Pantel Vokonas, Boston University
  • James Walsh, Veterans Administration Hospital
  • Paul Yu, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1977

Study Completion (Actual)

October 1, 1981

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

October 1, 1981

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: BHAT
    Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
  2. Study Forms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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