Improving Coronary Vascular Health in Women

NCT06843902 | Recruiting Phase 2 DMC

• 2 other identifiers: 2024P001952R01HL170905
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Coronary Flow Reserve

  Change in coronary flow reserve by cardiac positron emission tomography

  24 weeks

• Ectopic Adipose Tissue

  Change in ectopic adipose tissue reserve by cardiac computed tomography

  24 weeks

Secondary Outcomes (4)

• Kidney-related biomarkers

  24 weeks

• Metabolic biomarkers

  24 weeks

• Immune/inflammatory biomarkers

  24 weeks

• HIV-specific parameters

  24 weeks

Study Arms (2)

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

EXPERIMENTAL

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

Health Education

OTHER

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

Other: Health Education; Other: Subspecialty clinic referral

Interventions

Health Education OTHER

Health Education

Health Education; Health education plus subspecialty clinic referral for consideration of SGLT2 inhibitor therapy

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.

Health Education

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases; Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markella V Zanni, MD

  MGH/HMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Chu, NP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available 12 months after study completion and will remain available for a duration of time consonant with NIH policies.
• Access Criteria: Access criteria are as per the NIH BioLINCC data repository.

Locations

US (1)