Beta-Blocker Heart Attack Trial (BHAT) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 27, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 1977

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Beta-Blocker Heart Attack Trial (BHAT)

Official Title ^ICMJE

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: propranolol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 1981

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00000492

Responsible Party

Study ID Numbers ^ICMJE

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

October 1981

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP