Status:
COMPLETED
Heart Outcomes Prevention and Evaluation 4
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Conditions:
Hypertension
Cardiovascular Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and evaluate an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk assessment, tr...
Detailed Description
Study design: open-label, parallel cluster randomized controlled trial design. HT Phase: Up to 30 urban and rural communities in Canada, Colombia and Malaysia will be randomized to participate in an ...
Eligibility Criteria
Inclusion
- Individuals (≥ 50 years) with at least ONE of the following criteria:
- SBP ≥160 mmHg in one visit
- SBP 140-159 mmHg in one visit AND participant-reported medical diagnosis of hypertension
- SBP 140-159 mmHg in one visit AND participant taking anti-HT medication
- SBP ≥130 mmHg in one visit AND participant-reported medical diagnosis of diabetes
- SBP ≥130 mmHg in one visit AND participant taking medication for diabetes
- Participants that do not meet criteria 1-5 AND SBP 140-159 mmHg in one visit AND SBP ≥140 mmHg in a second visit ≥24 hours apart
Exclusion
- Refusal to Consent
- Actively involved in any study or heart health program that would compromise the protocol of HOPE-4
- Severe co-morbid condition with life expectancy \< 1 year
- Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
1438 Patients enrolled
Trial Details
Trial ID
NCT01826019
Start Date
August 1 2014
End Date
February 1 2019
Last Update
February 21 2019
Active Locations (4)
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1
Simon Fraser University
Burnaby, British Columbia, Canada, V5A 1S6
2
Population Health Research Institute
Hamilton, Ontario, Canada, L8L 2X2
3
FOSCAL
Floridablanca, Santander Department, Colombia
4
UniversitiTeknologi MARA (UiTM)
Sungai Buloh, Selangor, Malaysia, 47000