The Multiple Risk Factor Intervention Trial
(MRFIT)
Objectives:
The Multiple Risk Factor Intervention Trial (MRFIT)
sought to evaluate the effect of multiple risk factor intervention on mortality
from coronary heart disease in high risk men.
Background:
Prospective cohort studies, such as the Framingham
Heart Study, had established hypertension, cholesterol, and cigarette smoking
as potentially modifiable risk factors for the development of coronary heart
disease. A Task Force convened in 1970 determined that a multifactor
intervention trial, similar to the approach a physician would utilize, was
needed to ascertain whether behavior modification targeting multiple risk
factors could potentially reduce mortality from coronary heart disease. A
series of screening visits beginning in November of 1973 was used to establish
eligibility for the trial. At the first screening visit, blood pressure,
cigarette smoking history and cholesterol measurements were obtained to
establish risk for CHD. Men were excluded from additional screens if their risk
for CHD was low, had diabetes mellitus requiring medication, history of heart
attack, serum cholesterol of 350 mg/dL or more, or diastolic pressure of 115
mmHg or more. Measurements taken at the second screen included a resting ECG,
medical history, fasting blood draw, and glucose tolerance test. Men were
excluded at the second screen based on an ECG determined prior MI, body weight
greater than 150% of desirable, angina by Rose questionnaire, untreated
symptomatic diabetes, a diet incompatible with the MRFIT food pattern, or lipid
lowering treatment. Additional measurements were taken at the third screen and
men agreeing to the trial were randomized into either a special intervention
group or usual care.
Subjects:
A total of 12,866 men were randomized, roughly half
into each group. The special intervention group was advised to follow an eating
pattern designed to result in a nutrient intake of 30 percent to 35 percent of
calories from fat, with 10 (later 8) percent from saturated and 10 percent from
polyunsaturated fat; approximately 300 (later 250) mg of cholesterol; and
modification of carbohydrates as needed for individual requirements. This group
was also encouraged to cease cigarette smoking by a combination of techniques,
including counseling and audio-visual aids. Hypertension management was based
on a stepped-care program of weight reduction and drugs similar to that used in
the Hypertension Detection and Follow-up Program. Those in the usual care group
were referred to their personal physician or other source of care for such
management of their risk factors as considered appropriate by these providers.
The primary endpoint was death due to coronary heart disease. Men in both the
special intervention and usual care groups returned for assessment of changes
in risk factor levels annually. The primary endpoint was mortality from
coronary heart disease.
Conclusions:
After 6-8 years of followup, risk factor levels
declined in both groups but slightly more in the special intervention group.
Mortality from coronary heart disease and from all causes was not significantly
different among the two groups. (JAMA, 1982; 248:1465-77)
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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