Improving Coronary Vascular Health in Women
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * female sex-at-birth * self-report of HIV on stable antiretroviral therapy ≥180 days * age 45 -75 years * at least 1 of the following 3 conditions: i) type 2 diabetes mellitus ii) estimated glomerular filtration rate 30-60 ml/min/1.73 m2 iii) urine albumin to creatinine ratio \>30 mg/g * coronary flow reserve \<2.5 or stress myocardial blood flow \<2.5 on screening cardiac positron emission tomography/computed tomography Exclusion Criteria: * current SGLT2 inhibitor use * known allergy to SGLT2 inhibitor use * type 1 diabetes or ketoacidosis prone diabetes (diabetes with a history of ketoacidosis) * self-reported history of polycystic kidney disease * self-reported history of myocardial infarction, stroke, or coronary revascularization * stable or unstable angina * self-reported history of heart failure * hemoglobin A1c ≥8.5% at screen * uncontrolled hypertension at screen, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg * e