Actively Recruiting
Canagliflozin Targeting Vascular Inflammation: An Ottawa Imaging Study - A Pilot Study
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-06
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of targeted anti-inflammatory therapy using canagliflozin on aortic inflammation in patients with diabetes and stable coronary artery disease (CAD) who are over 60 days post-myocardial infarction. This pilot study uses a randomized, double-blinded design to compare canagliflozin with a placebo over a 6-month treatment period. The primary goal is to measure changes in FDG aortic uptake, an imaging marker of inflammation, between baseline and 6 months. Participants will be randomly assigned to receive either a daily 300 mg oral dose of canagliflozin or a placebo for six months. The study is conducted in a single center and participants in both groups will have similar clinical evaluations and imaging assessments. Blood samples will be collected at baseline, 3 months, and 6 months to measure biomarkers and other laboratory tests. FDG PET imaging with contrast CT scans will be performed at baseline and after 6 months to evaluate aortic inflammation. During the study, participants will have clinical evaluations and blood tests, including measures of blood sugar control, inflammation, liver and kidney function, and blood counts at baseline and every 3 months. FDG PET imaging will be repeated at 6 months to assess changes in the aorta. The primary outcome is the change in tissue-to-blood ratio (TBR) of the most diseased segment of the ascending aorta. The total study duration for each participant is 6 months, and safety and inflammation markers will be monitored throughout.
CONDITIONS
Brief Title
Canagliflozin Targeting Vascular Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable coronary artery disease at least 60 days after a myocardial infarction
- Diagnosis of diabetes
- Ability to provide informed consent
You will not qualify if you...
- Severe left ventricular dysfunction with ejection fraction less than 50%
- Decompensated heart failure
- Active infections such as pneumonia or skin infections requiring antibiotics
- Active inflammatory diseases or use of systemic anti-inflammatory therapy
- Pregnancy or breastfeeding
- Women of childbearing potential not using two forms of contraception during the study
- Men capable of fathering a child not using contraception
- Glomerular filtration rate below 50 ml/min/1.72m2
- Use of p-glycoprotein inhibitors or strong CYP3A4 inhibitors
- Low hemoglobin, white blood cell, or platelet counts
- History of severe liver disease or elevated liver enzymes
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take either canagliflozin 300 mg or placebo once daily for 6 months while undergoing clinical evaluations and blood sample collections.
Baseline visit and follow-up visits every 3 months
Trial Site Locations
Total: 1 location
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
Research Team
K
Kevin Boczar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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