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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00106886
First received: March 31, 2005
Last updated: September 16, 2005
Last verified: March 2005
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Myocardial Infarction
Stroke
Cancer
Drug: Folic acid, vitamin B6 and B12 or placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The composite of cardiovascular death, myocardial infarction (MI) and stroke

Secondary Outcome Measures:
  • 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
  • Total mortality
  • 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

Estimated Enrollment: 5000
Study Start Date: December 1999
Estimated Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106886

Locations
Canada, Ontario
McMaster University and Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Investigators
Principal Investigator: Eva M Lonn, MD MSc FRCPC FACC McMaster University
  More Information

Additional Information:
No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00106886     History of Changes
Other Study ID Numbers: HOPE-2, CIHR FRN # MT-15428
Study First Received: March 31, 2005
Last Updated: September 16, 2005
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
homocysteine
folic acid
micronutrients
multivitamins
vitamin supplements

Additional relevant MeSH terms:
Cardiovascular Diseases
Infarction
Myocardial Infarction
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Folic Acid
Vitamin B Complex
Vitamins
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014