Actively Recruiting
Improving Coronary Vascular Health in Women
Led by Massachusetts General Hospital · Updated on 2025-10-15
80
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed. We are conducting a study randomizing women with HIV and either diabetes, chronic kidney disease, or both to health education alone or to health education plus referral to see either an Endocrinologist or a Nephrologist in a subspecialty clinic for consideration of treatment with medication in a class known as sodium glucose transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors are clinically approved for use in patients with diabetes or chronic kidney disease but have been shown to be underutilized in people with HIV. One of our key analytic aims will be to test if SGLT2 inhibitor therapy results in improved blood flow through the large and small coronary arteries among women with HIV and either diabetes, chronic kidney disease, or both but who have no history of myocardial infarction. A second aim will be to test if subspecialty clinic referral (with or without SGLT2 inhibitor therapy prescription) results in improved blood flow through the large and small coronary arteries among the same group.
CONDITIONS
Official Title
Improving Coronary Vascular Health in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex at birth
- Self-report of HIV on stable antiretroviral therapy for at least 180 days
- Age between 45 and 75 years
- At least one of the following: type 2 diabetes mellitus; estimated glomerular filtration rate 30-60 ml/min/1.73 m2; urine albumin to creatinine ratio >30 mg/g
- Coronary flow reserve <2.5 or stress myocardial blood flow <2.5 on screening cardiac PET/CT scan
You will not qualify if you...
- Current use of SGLT2 inhibitors
- Known allergy to SGLT2 inhibitors
- Type 1 diabetes or diabetes prone to ketoacidosis
- History of polycystic kidney disease
- History of myocardial infarction, stroke, or coronary revascularization
- Stable or unstable angina
- History of heart failure
- Hemoglobin A1c 8.5% or higher at screening
- Uncontrolled hypertension at screening (systolic ≥180 mm Hg or diastolic ≥110 mm Hg)
- Estimated glomerular filtration rate below 30 ml/min/1.73 m2
- Currently on hemodialysis or peritoneal dialysis
- CD4 count below 400 cells/mm3
- Current treatment with systemic steroids or immune suppressants (excluding topical, UV therapy, ASA derivatives, or NSAIDs)
- Pregnancy or breastfeeding
- Known allergy to 13N Ammonia, 82Rubidium, Regadenoson, or Adenosine
- Concurrent enrollment in a conflicting research study
- History of recurrent urinary tract infections or vaginal yeast infections as specified
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Sarah Chu, NP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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