Improving Coronary Vascular Health in Women

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06843902
Phase
PHASE2
Status
Recruiting
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Conditions

  • Coronary Microvascular Dysfunction
  • HIV-1-infection
  • Metabolic Disease

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Health Education — OTHER
    Health Education
  • Subspecialty clinic referral — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 17, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Coronary Flow Reserve [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Markella Zanni, MD

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By research site
Massachusetts General Hospital· Boston, MA

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