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Lifestyle Heart Trial

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Hypertension
Myocardial Ischemia
Hypercholesterolemia
Coronary Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Coronary Disease

Treatments

Behavioral: diet, vegetarianism
Behavioral: exercise
Behavioral: diet, fat-restricted
Behavioral: smoking cessation

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000471
R01HL042554 (U.S. NIH Grant/Contract)
60

Details and patient eligibility

About

To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

Full description

BACKGROUND:

The trial was the first randomized, controlled trial to determine whether patients outside a hospital could be motivated to make and sustain comprehensive lifestyle changes and whether coronary disease regression could occur as a result of lifestyle changes alone.

DESIGN NARRATIVE:

Patients were randomly assigned to an experimental group or to a usual-care group. Experimental-group patients were prescribed a lifestyle program including a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. No animal products were allowed in the vegetarian diet except egg white and one cup per day of non-fat milk or yogurt. The diet contained approximately 10 percent of calories as fat. Control-group patients were not asked to make lifestyle changes. Coronary angiography was performed at baseline and at one year to assess progression or regression of disease. Patients were recruited into the trial between January 1986 and November 1988. The trial was supported prior to April 1989 from various sources other than the National Heart, Lung, and Blood Institute. Follow-up continued for four years.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Men and women, ages 35 to 75, with angiographically documented one, two, or three vessel coronary disease; no myocardial infarction during the preceeding six weeks; and not receiving streptokinase, alteplase, or lipid-lowering drugs.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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