Improving coronary blood flow in women with HIV and diabetes or chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 2 study enrolls women assigned female at birth with HIV and either type 2 diabetes or chronic kidney disease who demonstrate reduced coronary flow on PET/CT. After baseline history, exam, labs, and cardiac PET/CT, participants are randomized to health education alone or health education plus referral to an endocrinology or nephrology clinic for consideration of SGLT2 inhibitor therapy. Participants are followed for six months with repeat clinical assessment, laboratory testing, and cardiac PET/CT to measure change in coronary flow reserve and stress myocardial blood flow. The trial tests whether greater use of guideline-supported SGLT2 inhibitors in this undertreated population translates to measurable improvement in coronary microvascular and large-vessel blood flow.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* concurrent enrollment in conflicting research study
* self-reported history of recurrent urinary tract-infections (≥2 urinary tract infections within 6 months or ≥3 within a year) and/or recurrent vaginal yeast infections (≥2 vaginal yeast infections within 6 months or ≥3 within a year)
* currently receiving 24-hour-a-day home oxygen therapy

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Markella V Zanni, MD — Mgh/hms
• Study coordinator: Sarah Chu, NP
• Email: schu4@mgh.harvard.edu
• Phone: 617-724-6091

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.