RecruitingPhase 2NCT06843902

Improving Coronary Vascular Health in Women

ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)


Sponsor

Massachusetts General Hospital

Enrollment

80 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called empagliflozin (a drug commonly used for diabetes and heart failure) can improve blood flow to the heart in women living with HIV who also have reduced kidney function, diabetes, or protein in their urine. **You may be eligible if...** - You are a woman (female sex at birth) between 45 and 75 years old - You are HIV-positive and have been on stable HIV treatment for at least 6 months - You have at least one of the following: Type 2 diabetes, reduced kidney function, or protein in your urine - A specialized heart scan (cardiac PET/CT) has shown reduced blood flow to your heart **You may NOT be eligible if...** - You are already taking an SGLT2 inhibitor (a type of diabetes/heart medication) - You have had a recent heart attack or stroke - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHealth Education

Health Education

OTHERSubspecialty 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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06843902


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