Improving Coronary Vascular Health in Women
Recruiting · NCT06843902 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
- estimated glomerular filtration rate \<30 ml/min/1.73 m2
- currently receiving hemodialysis or peritoneal dialysis
- CD4 \<400 cell/mm3
- current treatment with systemic (oral, IV, IM or intra-articular) steroids or anti-inflammatory/immune suppressant therapies (excluding topical therapies, UV therapy, ASA-derivatives, or NSAIDs) for any indication, including kidney disease
- pregnancy or breastfeeding
- known allergy to 13N Ammonia/82Rubidium or to Regadenoson/Adenosine
- concurrent enrollment in conflicting research study
- self-reported history of recurrent urinary tract-infections (≥2 urinary tract infections within 6 months or ≥3 within a year) and/or recurrent vaginal yeast infections (≥2 vaginal yeast infections within 6 months or ≥3 within a year)
- currently receiving 24-hour-a-day home oxygen therapy
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States