Recruiting
Phase 2

SGLT2 Inhibitors

Sponsor:

Massachusetts General Hospital

Code:

NCT06843902

Conditions

HIV-1-infection

Coronary Microvascular Dysfunction

Metabolic Disease

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Health Education

Subspecialty clinic referral

Study Details

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.

Conditions

HIV-1-infection

Coronary Microvascular Dysfunction

Metabolic Disease

Study ID

NCT06843902

Start date

Apr 17, 2025

Status verified date

Oct, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Health education plus subspecialty clinic referral for consideration of SGLT2 inhibitor therapy

Participants randomized to this study arm will receive health education and will be referred to establish clinical care in either the MGH Lipid and Metabolism Clinic or the MGH Renal Clinic for consideration of SGLT2 inhibitor therapy. By study design (inclusion criteria), participants will have a clinical indication for SGLT2 inhibitor therapy (either diabetes or chronic kidney disease). SGLT2 inhibitor therapy (e.g. empagliflozin 10 mg by mouth daily or dapagliflozin 10 mg by mouth daily) may or may not be prescribed by the subspecialty clinician as part of routine clinical care, according to the clinician's clinical judgement. Participants will also receive health education.

other: Health Education

Participants randomized to this study arm will receive health education alone.

Interventions

Health Education

Health Education

Subspecialty clinic referral

This intervention will entail referred to establish clinical care in either the MGH Lipid and Metabolism Clinic or the MGH Renal Clinic for consideration of SGLT2 inhibitor therapy. SGLT2 inhibitor therapy (e.g. empagliflozin 10 mg by mouth daily or dapagliflozin 10 mg by mouth daily) may or may not be prescribed by the subspecialty clinician as part of routine clinical care, according to the clinician's clinical judgement.

Primary outcome measure

  • Coronary Flow Reserve [ Time Frame: 24 weeks ]
  • Ectopic Adipose Tissue [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Sarah Chu, NP

617-724-6091schu4@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 8, 2026

Last verified

Oct, 2025

Keywords

  • HIV
  • women
  • diabetes
  • chronic kidney disease
  • SGLT2 inhibitor therapy
  • coronary flow reserve
  • cardiovascular disease prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-08.