Heart hope: HIV-positive women may get better blood flow with common diabetes pills
NCT ID NCT06843902
First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study looks at whether SGLT2 inhibitors, a class of diabetes and kidney drugs, can improve blood flow through the heart's small arteries in women with HIV who also have diabetes or chronic kidney disease. Eighty women aged 45-75 will be randomly assigned to health education alone or health education plus a referral to a specialist who may prescribe an SGLT2 inhibitor. The goal is to see if the drug helps prevent heart attacks by improving coronary blood flow.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SGLT2 inhibitors (e.g., empagliflozin or dapagliflozin)
- What this could lead to
- If successful, this could show that SGLT2 inhibitors improve blood flow in the heart's small arteries, potentially reducing heart attack risk in women with HIV.
- What could go wrong
- This is a small, early-phase trial with only 80 participants. It tests a secondary effect of an already-approved drug, so the heart benefit may not be confirmed. The study also relies on doctors prescribing the drug, which may not happen for all participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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