Cardiovascular DiseasesPhase 2NCT00000471
Lifestyle Heart Trial
A Phase 2 study testing diet, vegetarianism, diet, fat-restricted and exercise in people with Cardiovascular Diseases and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease
- What is being tested?
- diet, vegetarianism, diet, fat-restricted and exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1989to Mar 1993
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases, Hypercholesterolemia, Hypertension
- Being tested
- diet, vegetarianism, diet, fat-restricted, exercise, smoking cessation
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Hypercholesterolemia, Hypertension, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet, vegetarianismBehavioural
diet, fat-restrictedBehavioural
exerciseBehavioural
smoking cessationBehavioural
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 startApr 1989
- Study completionMar 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 National Heart, Lung, and Blood Institute (NHLBI)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- K. Gould, University of TexasDean Ornish, University of California School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000471
- Sponsor's protocol ID
- 60
- Other IDs
- R01HL042554
- Status last verified
- Jan 2000
- First submitted
- 27 Oct 1999
- Last updated
- 13 Dec 2013
- Results posted
- No
Publications
Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
PubMed 1973470Gould KL, Ornish D, Kirkeeide R, Brown S, Stuart Y, Buchi M, Billings J, Armstrong W, Ports T, Scherwitz L. Improved stenosis geometry by quantitative coronary arteriography after vigorous risk factor modification. Am J Cardiol. 1992 Apr 1;69(9):845-53. doi: 10.1016/0002-9149(92)90781-s.
PubMed 1550011Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995 Sep 20;274(11):894-901. doi: 10.1001/jama.1995.03530110056036.
PubMed 7674504
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Heart Trial
- ClinicalTrials.gov ID
- NCT00000471
- Acronym / sponsor ID
- 60
- Conditions
- Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases, Hypercholesterolemia, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1989
- Study completion
- Mar 1993 (actual)
- 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 assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| diet, vegetarianism | Behavioural | – |
| diet, fat-restricted | Behavioural | – |
| exercise | Behavioural | – |
| smoking cessation | Behavioural | – |
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 13 Dec 2013.
- Background: PubMed 1973470Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
- Background: PubMed 1550011Gould KL, Ornish D, Kirkeeide R, Brown S, Stuart Y, Buchi M, Billings J, Armstrong W, Ports T, Scherwitz L. Improved stenosis geometry by quantitative coronary arteriography after vigorous risk factor modification. Am J Cardiol. 1992 Apr 1;69(9):845-53. doi: 10.1016/0002-9149(92)90781-s.
- Background: PubMed 7674504Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995 Sep 20;274(11):894-901. doi: 10.1001/jama.1995.03530110056036.
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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.
K. Gould
University of Texas
Dean Ornish
University of California School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diet, vegetarianism, diet, fat-restricted and exercise in people with Cardiovascular Diseases and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
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 13 Dec 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00000471, which also lists 3 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 13 Dec 2013.