HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)

September 16, 2005 updated by: Hamilton Health Sciences Corporation
The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease (CVD) remains a major cause of mortality and morbidity in most developed countries and accounts for approximately 40% of all deaths in Canada. Reductions in cholesterol, lowering of blood pressure and smoking cessation have been shown to be effective strategies in cardiovascular prevention; however, these major "classical cardiovascular risk factors" along with nonmodifiable risk factors, cannot fully explain why certain individuals develop atherosclerotic cardiovascular diseases, while others do not. Other "emerging" cardiovascular risk factors are currently under investigation. There is a large body of consistent, biologically plausible evidence linking hyperhomocyst(e)inemia to cardiovascular risk and the association is graded. A simple, nontoxic therapeutic intervention in the form of multivitamins - folic acid and vitamins B6 and B12 - has been shown to be highly effective in reducing homocyst(e)ine levels, irrespective of the underlying cause. To date, however, there are no good clinical trials evaluating the efficacy of homocyst(e)ine-lowering therapies in reducing major cardiovascular events. The impact of this simple intervention on cardiovascular morbidity and mortality remains to be demonstrated.

Study Hypothesis: Evaluate if long-term therapy with folic acid and vitamins B6 and B12 compared to placebo reduces the risk of major fatal and nonfatal cardiovascular events.

Importance of the Study: The "homocyst(e)ine theory of atherosclerosis" remains an important unanswered question in cardiovascular medicine. If indeed a combination of multivitamins is found to be effective in reducing cardiovascular events, it is expected that this safe, inexpensive and easily administered therapy would be widely used world-wide. Therefore, the results of this trial could have a significant public health impact.

Study Type

Interventional

Enrollment

5000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • McMaster University and Hamilton Health Sciences Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Women and men 55 years of age or over with established CVD and at high risk for future fatal and nonfatal CV events, defined as:

    1. Documented coronary artery disease (CAD);
    2. Documented peripheral vascular disease (PVD);
    3. Documented cerebrovascular disease;
    4. Diabetes with one of the following; additional cardiovascular risk factors:

    i) hypertension (BP >160 mmHg systolic or >90 mmHg diastolic or on treatment); ii) total cholesterol >5.2 mmol/L (>200 mg/dl); iii) HDL cholesterol <0.9 mmol/L (3.5 mg/dl); iv) current cigarette smoker; v) any evidence of previous vascular disease

  • Provision of informed consent

Exclusion Criteria:

  • Current use of any vitamin supplements containing folic acid >200 micrograms/day. The patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. If they agree, they can be randomized to the study following a one month wash-out period.
  • Known previous adverse reactions to folic acid and/or vitamin B6 and/or B12.
  • Planned cardiac, peripheral or cerebrovascular revascularization, defined as a decision taken by the patient and his or her physician(s) to perform surgical or percutaneous transluminal revascularization within the next 6 months.
  • Hemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
  • Constrictive pericarditis.
  • Complex congenital heart disease.
  • Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria.
  • Uncontrolled hypertension.
  • Cor pulmonale.
  • Heart transplant recipient.
  • Other important non-cardiovascular disease(s) expected to limit compliance and/or impact on patient's ability to complete the study, such as: *history of alcohol or drug abuse, *psychiatric disorders, *senility, *severe physical disability, *illnesses including terminal stage of cancer and other major systemic illnesses expected to limit the patient's ability to comply with the study protocol and to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The composite of cardiovascular death, myocardial infarction (MI) and stroke

Secondary Outcome Measures

Outcome Measure
Total mortality
Total major ischemic events (includes CV [cardiovascular] death, MI, stroke, hospitalizations for UA [unstable angina] and revascularizations)
Hospitalization for unstable angina
Hospitalization for congestive heart failure (CHF)
Hospitalization for revascularization procedures
Other hospitalizations
Diabetic complications (laser therapy, dialysis, nephropathy or new diagnosis of diabetes)
The composite of death due to cancer, hospitalization for cancer and new diagnosis of cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)
Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

March 31, 2005

First Submitted That Met QC Criteria

March 31, 2005

First Posted (ESTIMATE)

April 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2005

Last Update Submitted That Met QC Criteria

September 16, 2005

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE-2, CIHR FRN # MT-15428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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