Cardiovascular DiseasesPhase 3NCT00000487
Multiple Risk Factor Intervention Trial for the Prevention of Coronary Heart Disease (MRFIT)
A Phase 3 study testing antihypertensive agents, smoking cessation and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by University of Minnesota.
Trial summary
To determine for a group of men at high risk of death from coronary heart disease whether a special intervention program to lower serum cholesterol, reduce blood pressure, and eliminate cigarette smoking would result in a significant reduction in mortality from coronary heart disease. Read more about this study
- Who is it for?
- Ages 35 to 57 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- antihypertensive agents, smoking cessation and diet, fat-restricted
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1972to Jul 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 57 years
- Men only
- No healthy volunteers
- Adult
Men, ages 35-57. One or more of three risk factors--hypertension, hypercholesterolemia, and cigarette smoking.
Free from coronary heart disease.
About this study
To determine for a group of men at high risk of death from coronary heart disease whether a special intervention program to lower serum cholesterol, reduce blood pressure, and eliminate cigarette smoking would result in a significant reduction in mortality from coronary heart disease.
Read the detailed description
BACKGROUND:
Research findings from prospective epidemiological studies in a number of populations in the United States over the past 40 years have convincingly established that elevated blood cholesterol, elevated blood pressure, and cigarette smoking are risk factors associated with accelerated development of myocardial infarction, sudden death, and death from coronary heart disease. These are not the only risk factors associated with premature development of CHD, but these factors are modifiable and provide a strong expectation that a reduction of these factors should have a beneficial result of reducing the rate of development of premature heart attacks.
A multifactor approach to risk factor reduction closely resembles the type of intervention that would be carried out by a physician in his treatment of a patient. The general concept for such a trial was endorsed by the Arteriosclerosis Task Force in its 1970 report to the Institute.
Volunteers were selected for the trial through a series of three screening visits, which began in November 1973 and were completed by February 28, 1976. From among 361,662 men seen at first screening, 12,866 were found to be eligible and were randomized into the trial. Half of the participants were assigned to the special intervention group and half to the usual care 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. A medical history was taken and a physical examination performed. An electrocardiogram was also obtained for centralized reading to identify non-fatal myocardial infarction as an additional endpoint.
Participating in the study were 22 clinical centers across the United States, a coordinating center, central laboratory, two ECG reading centers, and lipid standardization laboratory, as well as a drug distribution center. The trial has concluded, with the main mortality results published in September l982. Active follow-up was terminated on schedule on February 28, l982, with final determination of vital status as of that date accomplished for 99.6 percent of the study population.
DESIGN NARRATIVE:
A randomized, non-blind design with two groups and fixed sample size. The experimental group underwent a modified-fat diet, antihypertensive therapy, and education related to lifestyle and smoking. Those in the control group were referred to their own physicians for treatment.
Post-trial mortality surveillance of the 12,300 participants still living at the end of active intervention in February 1982 continued through June 1998 under grant support (R01HL43232). Use of the National Death Index for mortality surveillance of the 361,662 men screened for the MRFIT continued thorough July 1998 under grant support (R01HL28715). Recent analyses focus on the relationship of dietary factors, such as sodium, during the trial with post-trial mortality. Papers are in progress on further predictors of diabetes mellitus; indicators of cardiovascular disease morbidity and risk of death; and prognostic importance of changes in indices of left ventricular hypertrophy and ischemia.
- Being tested
- antihypertensive agents, smoking cessation, diet, fat-restricted, diuretics
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antihypertensive agentsDrug
smoking cessationBehavioural
diet, fat-restrictedBehavioural
diureticsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJun 1972
- Study completionJul 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (161)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Marcus Kjelsberg, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000487
- Sponsor's protocol ID
- 6
- Other IDs
- R01HL043232
- Status last verified
- Feb 2016
- First submitted
- 27 Oct 1999
- Last updated
- 25 Feb 2016
- Results posted
- No
Publications
Stamler J, Paul O, Berkson DM, et al: The New National Cooperative Multiple Risk Factor Intervention Trial (Heart Attack Prevention Program). Chicago Medicine, 76:1047-1048, 1973.
Multiple Risk Factor Intervention Trial Group: Multiple Risk Factor Intervention Trial. Proceedings of the Nutrition Behavioral Research Conference. NHLBI, NIH, DHEW Publication No. (NIH) 76-978, p. ll, l975.
Multiple Risk Factor Intervention Trial Group: Public Annual Report, Multiple Risk Factor Intervention Trial, June 30, l974 to July l, l975. U.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health, DHEW Publication No. (NIH) 76-l000, August, l975.
Multiple Risk Factor Intervention Trial Group: Smoking Cessation Activities in the Multiple Risk Factor Intervention Trial: A Preliminary Report.J. Steinfeld et al (Eds). Smoking & Health: Proceedings of the Third World Conference on Smoking and Health, June 2-5, l975, II Health Consequences, Education, Cessation Activities, and Social Action, U.S. Government Printing Office, Washington, D.C., l976, 6l3-6l7.
The multiple risk factor intervention trial (MRFIT). A national study of primary prevention of coronary heart disease. JAMA. 1976 Feb 23;235(8):825-7. No abstract available.
PubMed 946311Multiple Risk Factor Intervention Trial Group: Public Annual Report, Multiple Risk Factor Intervention Trial, June 30, l975 to July l, l976. U.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health, DHEW Publication No. (NIH) 77-l2ll, August, l976.
Rautaharju PM, Seale D, Prineas R, Wolf H, Crow R, Warren J. Changing electrocardiographic recording technology and diagnostic accuracy of myocardial infarction criteria. Improved standards for evaluation of ECG measurement precision. J Electrocardiol. 1978 Oct;11(4):321-30. doi: 10.1016/s0022-0736(78)80137-x.
PubMed 361920Hulley S, Ashman P, Kuller L, Lasser N, Sherwin R. HDL-cholesterol levels in the Multiple Risk Factor Intervention Trial (MRFIT) by the MRFIT Research Group 1,2. Lipids. 1979 Jan;14(1):119-123. doi: 10.1007/BF02533580.
PubMed 218069Ockene J: Multiple Risk Factor Intervention Trial: Smoking Cessation Procedures and Cessation Patterns for a Large Cohort of MRFIT Participants. In Schwartz J (Ed): Progress in Smoking Cessation, American Cancer Society, New York, p. 183-198, 1979.
The MRFIT behavior pattern study--I. Study design, procedures, and reproducibility of behavior pattern judgments. The Multiple Risk Factor Intervention Trial Group. J Chronic Dis. 1979;32(4):293-305. No abstract available.
PubMed 447782Benfari RC, McIntyre K, Eaker E, Blumberg S, Paul O. The psychological effects of differential treatment of a high risk sample in a randomized clinical trial. Am J Public Health. 1979 Oct;69(10):996-1000. doi: 10.2105/ajph.69.10.996.
PubMed 484765Farrand ME, Mojonnier L. Nutrition in the Multiple Risk Factor Intervention Trial (MRFIT). J Am Diet Assoc. 1980 Apr;76(4):347-51.
PubMed 7391467Kuller L, Neaton J, Caggiula A, Falvo-Gerard L. Primary prevention of heart attacks: the multiple risk factor intervention trial. Am J Epidemiol. 1980 Aug;112(2):185-99. doi: 10.1093/oxfordjournals.aje.a112984. No abstract available.
PubMed 6998287Rautaharju PM, Prineas RJ, Crow RS, Seale D, Furberg C. The effect of modified limb electrode positions on electrocardiographic wave amplitudes. J Electrocardiol. 1980 Apr;13(2):109-13. doi: 10.1016/s0022-0736(80)80040-9.
PubMed 7365351Mandriota R, Bunkers B, Wilcox ME. Nutrition intervention strategies in the Multiple Risk Factor Intervention Trial (MRFIT). J Am Diet Assoc. 1980 Aug;77(2):138-40.
PubMed 7400494
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Risk Factor Intervention Trial for the Prevention of Coronary Heart Disease (MRFIT)
- ClinicalTrials.gov ID
- NCT00000487
- Acronym / sponsor ID
- 6
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 1972
- Study completion
- Jul 1998
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine for a group of men at high risk of death from coronary heart disease whether a special intervention program to lower serum cholesterol, reduce blood pressure, and eliminate cigarette smoking would result in a significant reduction in mortality from coronary heart disease.
Detailed description
BACKGROUND:
Research findings from prospective epidemiological studies in a number of populations in the United States over the past 40 years have convincingly established that elevated blood cholesterol, elevated blood pressure, and cigarette smoking are risk factors associated with accelerated development of myocardial infarction, sudden death, and death from coronary heart disease. These are not the only risk factors associated with premature development of CHD, but these factors are modifiable and provide a strong expectation that a reduction of these factors should have a beneficial result of reducing the rate of development of premature heart attacks.
A multifactor approach to risk factor reduction closely resembles the type of intervention that would be carried out by a physician in his treatment of a patient. The general concept for such a trial was endorsed by the Arteriosclerosis Task Force in its 1970 report to the Institute.
Volunteers were selected for the trial through a series of three screening visits, which began in November 1973 and were completed by February 28, 1976. From among 361,662 men seen at first screening, 12,866 were found to be eligible and were randomized into the trial. Half of the participants were assigned to the special intervention group and half to the usual care 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. A medical history was taken and a physical examination performed. An electrocardiogram was also obtained for centralized reading to identify non-fatal myocardial infarction as an additional endpoint.
Participating in the study were 22 clinical centers across the United States, a coordinating center, central laboratory, two ECG reading centers, and lipid standardization laboratory, as well as a drug distribution center. The trial has concluded, with the main mortality results published in September l982. Active follow-up was terminated on schedule on February 28, l982, with final determination of vital status as of that date accomplished for 99.6 percent of the study population.
DESIGN NARRATIVE:
A randomized, non-blind design with two groups and fixed sample size. The experimental group underwent a modified-fat diet, antihypertensive therapy, and education related to lifestyle and smoking. Those in the control group were referred to their own physicians for treatment.
Post-trial mortality surveillance of the 12,300 participants still living at the end of active intervention in February 1982 continued through June 1998 under grant support (R01HL43232). Use of the National Death Index for mortality surveillance of the 361,662 men screened for the MRFIT continued thorough July 1998 under grant support (R01HL28715). Recent analyses focus on the relationship of dietary factors, such as sodium, during the trial with post-trial mortality. Papers are in progress on further predictors of diabetes mellitus; indicators of cardiovascular disease morbidity and risk of death; and prognostic importance of changes in indices of left ventricular hypertrophy and ischemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 35 to 57 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antihypertensive agents | Drug | – |
| smoking cessation | Behavioural | – |
| diet, fat-restricted | Behavioural | – |
| diuretics | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- BackgroundStamler J, Paul O, Berkson DM, et al: The New National Cooperative Multiple Risk Factor Intervention Trial (Heart Attack Prevention Program). Chicago Medicine, 76:1047-1048, 1973.
- BackgroundMultiple Risk Factor Intervention Trial Group: Multiple Risk Factor Intervention Trial. Proceedings of the Nutrition Behavioral Research Conference. NHLBI, NIH, DHEW Publication No. (NIH) 76-978, p. ll, l975.
- BackgroundMultiple Risk Factor Intervention Trial Group: Public Annual Report, Multiple Risk Factor Intervention Trial, June 30, l974 to July l, l975. U.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health, DHEW Publication No. (NIH) 76-l000, August, l975.
- BackgroundMultiple Risk Factor Intervention Trial Group: Smoking Cessation Activities in the Multiple Risk Factor Intervention Trial: A Preliminary Report.J. Steinfeld et al (Eds). Smoking & Health: Proceedings of the Third World Conference on Smoking and Health, June 2-5, l975, II Health Consequences, Education, Cessation Activities, and Social Action, U.S. Government Printing Office, Washington, D.C., l976, 6l3-6l7.
- Background: PubMed 946311The multiple risk factor intervention trial (MRFIT). A national study of primary prevention of coronary heart disease. JAMA. 1976 Feb 23;235(8):825-7. No abstract available.
- BackgroundMultiple Risk Factor Intervention Trial Group: Public Annual Report, Multiple Risk Factor Intervention Trial, June 30, l975 to July l, l976. U.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health, DHEW Publication No. (NIH) 77-l2ll, August, l976.
- Background: PubMed 361920Rautaharju PM, Seale D, Prineas R, Wolf H, Crow R, Warren J. Changing electrocardiographic recording technology and diagnostic accuracy of myocardial infarction criteria. Improved standards for evaluation of ECG measurement precision. J Electrocardiol. 1978 Oct;11(4):321-30. doi: 10.1016/s0022-0736(78)80137-x.
- Background: PubMed 218069Hulley S, Ashman P, Kuller L, Lasser N, Sherwin R. HDL-cholesterol levels in the Multiple Risk Factor Intervention Trial (MRFIT) by the MRFIT Research Group 1,2. Lipids. 1979 Jan;14(1):119-123. doi: 10.1007/BF02533580.
- BackgroundOckene J: Multiple Risk Factor Intervention Trial: Smoking Cessation Procedures and Cessation Patterns for a Large Cohort of MRFIT Participants. In Schwartz J (Ed): Progress in Smoking Cessation, American Cancer Society, New York, p. 183-198, 1979.
- Background: PubMed 447782The MRFIT behavior pattern study--I. Study design, procedures, and reproducibility of behavior pattern judgments. The Multiple Risk Factor Intervention Trial Group. J Chronic Dis. 1979;32(4):293-305. No abstract available.
- Background: PubMed 484765Benfari RC, McIntyre K, Eaker E, Blumberg S, Paul O. The psychological effects of differential treatment of a high risk sample in a randomized clinical trial. Am J Public Health. 1979 Oct;69(10):996-1000. doi: 10.2105/ajph.69.10.996.
- Background: PubMed 7391467Farrand ME, Mojonnier L. Nutrition in the Multiple Risk Factor Intervention Trial (MRFIT). J Am Diet Assoc. 1980 Apr;76(4):347-51.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Kjelsberg
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing antihypertensive agents, smoking cessation and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000487, which also lists 161 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.