NCT06843902
Improving Coronary Vascular Health in Women
Recruiting
PHASE2Ages 45–75InterventionalPreventionMassachusetts General HospitalInvestigator-initiated
~80 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:Health EducationSubspecialty clinic referral
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Coronary Flow Reserve
Measured over 24 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Markella V Zanni, MD · PRINCIPAL_INVESTIGATOR · MGH/HMS
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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)
What this trial measures
- Coronary Flow Reserve24 weeks
Change in coronary flow reserve by cardiac positron emission tomography
- Ectopic Adipose Tissue24 weeks
Change in ectopic adipose tissue reserve by cardiac computed tomography