Status:
RECRUITING
The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cardiovascular Diseases
Cardiovascular Risk Factors
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Despite the availability of medications, many people around the world continue to live with long-term health problems like heart disease, stroke and diabetes. In Canada, heart disease is a leading cau...
Eligibility Criteria
Inclusion
- Be taking statin medication with or without other antihyperlipidemic therapy (stable dose for at least 3-months).
- Fall under either of the 2 categories:
- 1\) Secondary prevention participants: males and females ≥45 years of age with established atherosclerotic cardiovascular disease (ASCVD) defined as at least one of the following: i. Prior myocardial infarction (MI); ii. Acute coronary syndrome (ACS); iii. Stroke/TIA; iv. Coronary revascularization; v. Documented carotid disease (endarterectomy, carotid stenosis ≥50%); vi. Stable angina; vii. Coronary artery disease (CAD) by angiography; viii. Peripheral artery disease (PAD); ix. Abdominal aortic aneurysm (AAA)
- 2\) High-risk primary prevention participants: males and females ≥50 years of age plus type 2 diabetes requiring treatment with medication and at least one additional risk factor: i. Males ≥55 years of age and females ≥65 years of age; ii. Cigarette smoker or stopped smoking within 3 months before Visit 1; iii. Hypertension and on antihypertensive medication for at least 6-months; iv. Chronic kidney disease (CKD); v. Retinopathy, defined as any of the following: non-proliferative retinopathy, pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or a history of photocoagulation
- Be on a stable dose for at least 3-months of all antihyperlipidemic, antihyperglycemic, antihypertensive, and antiobesity therapies.
- Have a family physician in Ontario and a valid Ontario Health Card.
- Have regular access to an online portal
- Be proficient in English.
Exclusion
- Major disease expected to result in death within 2 years (except cardiovascular disease)
- Active sever liver disease
- Malabsorption disorders
- Drug or alcohol abuse disorders (within past 6 months)
- Intolerance or allergies to soy protein and tree nuts, peanuts, or seeds
- Planned coronary intervention or any major surgical procedure
- Participation in another clinical trial (within past 3 months)
- End stage renal disease (requirement for peritoneal dialysis or hemodialysis for renal insufficiency or eGFR \<30 mL/min)
- Any condition or therapy which might pose a risk to the patient or make participation in the study not be in the best interest of the patient as assessed by the investigator
- Documented severe (New York Heart Association \[NYHA\] class IV) heart failure
- Mental/psychological impairment expected to affect adherence to the study protocol
- Known AIDS (HIV-positive patients without AIDS are allowed)
- Women planning on becoming pregnant within the first year of the intervention
- Unable to provide informed consent: Appear unable to comprehend the study protocol during the interview process or to understand and communicate in English sufficiently for informed consent.
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2035
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06919302
Start Date
August 15 2025
End Date
June 1 2035
Last Update
November 26 2025
Active Locations (1)
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1
C. David Naylor Building
Toronto, Ontario, Canada, M5S1A8