Improving Coronary Vascular Health in Women

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

Interventions

OTHER

Health Education

Health Education

OTHER

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Markella V Zanni, MD · MGH/HMS

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-17

Primary Completion

2029-03-31

Completion

2029-06-30

Countries

• United States

Study Locations