Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Hamilton Health Sciences Corporation
Sponsor:
Collaborators:
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Grand Challenges Canada
Global Alliance for Chronic Disease
Cadila Pharmaceuticals Ltd
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01826019
First received: March 31, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The overall objective of the HOPE-4 study, Phases (hypertension (HT) and cardiovascular disease (CVD)), is to develop and test a program for cardiovascular disease risk assessment and treatment involving: (1) simple screening and treatment guidelines implemented by non-physician health workers (NPHW); (2) single pill containing blood pressure and cholesterol lowering drugs; and (3) family or friends and mobile phone technology to help participants comply with the treatment regimen. This program has the potential to reduce major cardiovascular events by 35% over 6 years, as compared to usual care.


Condition Intervention Phase
Hypertension
Cardiovascular Disease
Other: Intervention
Other: Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heart Outcomes Prevention and Evaluation 4 (HOPE-4)

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • The mean difference in change in systolic blood pressure (BP) between the intervention and control communities from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT phase) ] [ Designated as safety issue: No ]
  • Difference in a composite of major CV events [(CV death, MI, stroke, congestive heart failure (CHF) and CV hospitalizations (e.g. AF, unstable or new onset angina, CHF, arterial revascularization), and end-stage renal disease] from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean differences in calculated INTERHEART risk score from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT Phase) ] [ Designated as safety issue: No ]
  • The difference in the proportion of participants on antihypertensive treatment and well-controlled from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT Phase) ] [ Designated as safety issue: No ]
  • Difference in number of initiations, discontinuations, and up/down titrations of PolyCap formulations, as well as number of hospitalizations and CVD events from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT Phase) ] [ Designated as safety issue: Yes ]
  • Difference in the individual components of the primary outcome from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ] [ Designated as safety issue: No ]
  • Mean change in systolic BP, HDL, and LDL from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ] [ Designated as safety issue: No ]
  • Mean difference in calculated lab and non-lab based INTERHEART Risk Score from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ] [ Designated as safety issue: No ]
  • Difference in number of initiations, discontinuations, and up/down titrations of PolyCap formulations from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ] [ Designated as safety issue: Yes ]
  • Mean change in systolic BP from baseline to 6 months [ Time Frame: Baseline to 6 months(HT Phase) ] [ Designated as safety issue: No ]
  • The mean differences in calculated non-lab based INTERHEART risk score from baseline to 6 months [ Time Frame: Baseline to 6 months(HT Phase) ] [ Designated as safety issue: No ]
  • The difference in the proportion of participants on antihypertensive treatment and well-controlled from baseline to 6 months. [ Time Frame: Baseline to 6 months (HT Phase) ] [ Designated as safety issue: No ]
  • The mean change in HDL and LDL values from baseline to 1 year. [ Time Frame: Baseline to 1 year (HT Phase) ] [ Designated as safety issue: No ]
  • Difference in number of hypertension related emergencies reported from baseline to 6 years. [ Time Frame: Baseline to 6 Years (CVD Phase) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Health economic evaluations - measure/calculate the unit costs and the quantity used of each of the components of the intervention and in usual care in the participating countries. [ Time Frame: Baseline to 6 years ] [ Designated as safety issue: No ]
    We will collect data that will allow us to determine (i) the costs of the suggested programs (i.e. intervention package) and the costs of what is being provided currently for CVD assessment and management in the communities studied (i.e. control).


Estimated Enrollment: 9500
Study Start Date: August 2014
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Intensive CV risk detection, counselling and follow-up program by non-physician health workers (NPHW); open-label fixed-dose combination pill therapy (Polycap) in accordance with treatment algorithm; use of treatment supporters and mobile phone technology to reinforce adherence.
Other: Intervention
In intervention communities, management plans will be developed by the NPHW for all enrolled participants. The NPHWs will educate participants about CVD, HT treatment, lifestyle modifications and initiate therapy according to the modified WHO CVD risk-management algorithm, including referral of high-risk patients to physicians and safety monitoring where appropriate. Participants in intervention communities will have support from family or friends (treatment supporters) and will receive educational materials and treatment reminders using text-messaging, email, and printed materials, as appropriate for the participant and the community setting. Standard and half-dose Polycap formulations will be provided to the NPHWs and supervising physicians for participant treatment.
Control - Usual Care
Participants in control communities will be referred to usual care.
Other: Usual Care
At initial screening, eligible participants will be provided with a brief information booklet/leaflet (customized to the community or region) regarding lifestyle modification and be advised to see their usual physician for care that is considered appropriate. No structured interventions will be employed.

Detailed Description:

Study design: open-label, cluster randomized controlled trial design.

HT Phase: 50 urban and rural communities in Colombia and Malaysia will be randomized to participate in an intensive cardiovascular (CV) risk detection and control program by non-physician health workers (NPHW) or to care as usual for 12 months.

CVD Phase: Continuation and expansion of HT Phase to include a total of 190 urban and rural communities in countries within Asia (India, Malaysia, Philippines), South America (Colombia, Argentina), Sub-Saharan Africa (South Africa, Tanzania, Rwanda) and Canada that will be allocated to participate in the intensive CV risk detection and control program by NPHW or to care as usual for a target of 6 years.

Communities will be randomized 1:1 with a central randomization list to either a) intervention or b) control.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >= 50 years of age with at least one of the following:
  • systolic blood pressure (SBP) 140-159 mmHg on 2 separate visits (>= 24 hours between visits)
  • SBP >= 160 mm Hg on one visit
  • Participant-reported history of clinical diagnosis of HT and taking anti-HT medications
  • For diabetes, myocardial infarction (MI), cerebrovascular accident (CVA), coronary artery bypass surgery or coronary angioplasty (+/- stent): participant reported history of clinical diagnosis
  • Angina: participant-reported history of clinical diagnosis PLUS at least one of the following:

    • Definite angina (substernal chest pain that is provoked by exertion (exercise or stress) and is relieved by rest or nitroglycerin OR
    • Prescription of beta blockers, nitrates, calcium channel blockers or other antianginal drugs
  • Congestive heart failure (CHF): participant-reported history of clinical diagnosis PLUS at least one of the following:

    • Total score of ≥ 5 points (rest dyspnea (4 points), orthopnea (4 points), paroxysmal nocturnal dyspnea (3 points), dyspnea on flat surface (2 points), dyspnea on climbing (1 point) OR
    • Prescription of furosemide (or similar loop diuretic)

General Exclusion Criteria:

  • Refusal to Consent
  • Actively involved in any study 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

Polycap Exclusion Criteria:

  • Participants with a clear contraindication or intolerance to statin, beta blocker (e.g. asthma), or diuretic in the judgment of the physician
  • Participants with chronic liver disease or abnormal liver function (i.e. Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN))
  • Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) > 3x ULN
  • Severe renal impairment (serum creatinine > 200 umol/L)
  • Potassium (K) > 5.0 mmol/L or contraindication to ACE Inhibitor
  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: NCT01826019

Contacts
Contact: Tara L McCready, PhD, MBA 905-527-4322 ext 40439 tara.mccready@phri.ca

Locations
Canada, Ontario
Population Health Research Institute Active, not recruiting
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Grand Challenges Canada
Global Alliance for Chronic Disease
Cadila Pharmaceuticals Ltd
Investigators
Principal Investigator: Jon-David Schwalm, MD, MSc McMaster University and Hamilton Health Sciences Corp.
Principal Investigator: Salim Yusuf, MD, DPhil McMaster University and Hamilton Health Sciences Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01826019     History of Changes
Other Study ID Numbers: HOPE-4
Study First Received: March 31, 2013
Last Updated: June 30, 2014
Health Authority: Colombia: Ministry of Health and Social Protection
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014