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Beta-Blocker Heart Attack Trial (BHAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000492
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition Intervention Phase
Arrhythmia Cardiovascular Diseases Coronary Disease Death, Sudden, Cardiac Heart Diseases Myocardial Infarction Myocardial Ischemia Ventricular Fibrillation Drug: propranolol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1977
Study Completion Date: October 1981
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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, ages 30 to 69. Documented myocardial infarction.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000492


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Allan Barker Salt Lake Clinic Research Foundation
OverallOfficial: Nemat Borhani University of California, Davis
OverallOfficial: Gerald Breneman Henry Ford Hospital
OverallOfficial: Frank Canosa Miami Heart Institute
OverallOfficial: Robert Capone Rhode Island Hospital
OverallOfficial: Richard Crow University of Minnesota - Clinical and Translational Science Institute
OverallOfficial: Alan Forker (participated until Feb University of Nebraska
OverallOfficial: Peter Gazes University of South Carolina
OverallOfficial: John Gregory Atlantic Health System
OverallOfficial: John Grover Kaiser Foundation Research Institute
OverallOfficial: Olga Haring Northwestern University
OverallOfficial: Julian Haywood University of Southern California
OverallOfficial: William Holmes Lankenau Hospital
OverallOfficial: Frank Ibbott Bio-Science Laboratories
OverallOfficial: Robert Kohn State University of New York
OverallOfficial: Robert Kramer Long Island Jewish-Hillside Medical Center
OverallOfficial: Peter Kuo New Jersey College of Medicine and Dentistry-Rutgers
OverallOfficial: Charles Laubach Geisinger Clinic
OverallOfficial: Edgar Lichstein Maimonides Medical Center
OverallOfficial: Louis Matthews Dartmouth-Hitchcock Medical Center
OverallOfficial: Gordon Maurice Providence Medical Center
OverallOfficial: J. McNamara Pacific Health Research Institute
OverallOfficial: E. Michau Veterans Administration Hospital
OverallOfficial: Richard Miller Baylor College of Medicine
OverallOfficial: Joel Morganroth Anthropometrics Heart Clinic
OverallOfficial: Marvin Murphy
OverallOfficial: Robert Peters University of California
OverallOfficial: Thaddeus Prout Greater Baltimore Medical Center
OverallOfficial: Phillip Ranheim Mount Sinai Hospital, New York
OverallOfficial: David Richardson Medical College of Virginia
OverallOfficial: Robert Schlant Emory University
OverallOfficial: James Schoenberger Rush-Presbyterian-St.Luke's Hospital
OverallOfficial: Pierre Theroux Montreal Heart Institute
OverallOfficial: Pantel Vokonas Boston University
OverallOfficial: James Walsh Veterans Administration Hospital
OverallOfficial: Gary Wilner NorthShore University HealthSystem Research Institute
OverallOfficial: Paul Yu University of Rochester School of Medicine and Dentistry
  More Information

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

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: BHAT
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.

ClinicalTrials.gov Identifier: NCT00000492     History of Changes
Other Study ID Numbers: 11
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
Last Verified: October 1981

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Ventricular Fibrillation
Death, Sudden
Death, Sudden, Cardiac
Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Arrhythmias, Cardiac
Death
Heart Arrest
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents