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

ISRCTN ISRCTN14017017
DOI https://doi.org/10.1186/ISRCTN14017017
ClinicalTrials.gov number NCT00106886
Secondary identifying numbers MCT-15428
Submission date
05/09/2005
Registration date
05/09/2005
Last edited
03/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Dr Eva Lonn
Scientific

HGH-McMaster Clinic
237 Barton Street East
Room 254
Hamilton
L8L 2X2
Canada

Phone +1 905 526 0970
Email lonnem@mcmaster.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHOPE-2
Study hypothesis1. To evaluate whether prolonged therapy with folic acid and vitamins B6 and B12 compared to placebo reduces the risk of cardiovascular death, myocardial infarction (MI) and stroke (major fatal and non-fatal cardiovascular [CV] events)
2. To evaluate the effects of the study intervention on major fatal and non-fatal CV and revascularisation procedures and on total important ischaemic events
Ethics approval(s)Hamilton Health Sciences Corporation and McMaster University approved on the 17th November 1999.
ConditionCardiovascular disease, myocardial infarction (MI), stroke, cancer
InterventionCombination pill containing: Folic acid 2.5 mg, vitamin B6 50 mg, vitamin B12 1 mg, or placebo
Intervention typeSupplement
Primary outcome measureThe composite of cardiovascular death, myocardial infarction (MI) and stroke.
Secondary outcome measures1. Total major ischaemic events, including CV death, MI, stroke, hospitalisations for unstable angina and revascularisations
2. Total mortality
3. Hospitalisation for unstable angina (UA)
4. Hospitalisation for congestive heart failure (CHF)
5. Revascularisation procedures
6. Incident cancer
7. Cancer death
Overall study start date01/04/1999
Overall study end date31/03/2006

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants5552
Participant inclusion criteria1. 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:
1.1. Documented coronary artery disease (CAD)
1.2. Documented peripheral vascular disease (PVD)
1.3. Documented cerebrovascular disease
1.4. Diabetes with one of the following additional cardiovascular risk factors:
1.4.1. Hypertension (blood pressure [BP] greater than 160 mmHg systolic or greater than 90 mmHg diastolic or on treatment)
1.4.2. Total cholesterol greater than 5.2 mmol/l (greater than 200 mg/dl)
1.4.3. High density lipoprotein (HDL) cholesterol less than 0.9 mmol/l (3.5 mg/dl)
1.4.4. Current cigarette smoker
1.4.5. Any evidence of previous vascular disease
2. Provision of informed consent
Participant exclusion criteria1. Current use of any vitamin supplements containing folic acid greater than 200 µg/day. Patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. If they agree they can be randomised to the study.
2. Known previous adverse reactions to folic acid, vitamin B6 or B12
3. 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 revascularisation within the next 6 months
4. Haemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve)
5. Constrictive pericarditis
6. Complex congenital heart disease
7. Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria)
8. Uncontrolled hypertension
9. Cor pulmonale
10. Heart transplant recipient
11. 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 cancer and other major systemic illnesses expected to limit the patient’s ability to comply with the study protocol and to complete the study
Recruitment start date01/04/1999
Recruitment end date31/03/2006

Locations

Countries of recruitment

  • Canada

Study participating centre

HGH-McMaster Clinic
Hamilton
L8L 2X2
Canada

Sponsor information

McMaster University (Canada)
University/education

Office of the Associate Dean
Research
McMaster University
Faculty of Health Sciences
1200 Main Street West
Room HSC-3N8
Hamilton
L8N 3Z5
Canada

Website http://www.mcmaster.ca/
ROR logo "ROR" https://ror.org/02fa3aq29

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15428)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/04/2006 Yes No
Results article results 05/06/2007 Yes No
Results article results 01/04/2009 Yes No