Improving Coronary Vascular Health in Women

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45-75
SponsorMassachusetts General Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Health Education

    Other intervention

    Health Education

  • Subspecialty clinic referral

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Health education plus subspecialty clinic referral for consideration of SGLT2 inhibitor therapyExperimental treatment 1 intervention
Group B: Health EducationOther 2 interventions

Trial outcomes

Primary outcomes

1

Coronary Flow Reserve

Change in coronary flow reserve by cardiac positron emission tomography

Time frame
24 weeks
2

Ectopic Adipose Tissue

Change in ectopic adipose tissue reserve by cardiac computed tomography

Time frame
24 weeks

Secondary outcomes

1

Kidney-related biomarkers

Urine and serum biomarkers related to kidney health and disease

Time frame
24 weeks
2

Metabolic biomarkers

Urine and serum biomarkers relating to metabolism (including glucose and lipid metabolism)

Time frame
24 weeks
3

Immune/inflammatory biomarkers

Urine and serum biomarkers relating to inflammation and immune activation

Time frame
24 weeks
4

HIV-specific parameters

Serum variables relating to HIV disease (such as HIV-1 viral load, CD4 T cell count, CD8 T cell count)

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator