NCT06843902RecruitingPhase 2
Improving Coronary Vascular Health in Women
ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 17 Apr 2025
- Primary completion date
- Mar 2029
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Chronic kidney disease, HIV, Type 2 diabetes
- NCT number
- NCT06843902
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 17 Apr 2025 to the primary completion date, Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current SGLT2 inhibitor use
- currently receiving hemodialysis or peritoneal dialysis
- 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
- concurrent enrollment in conflicting research study
- currently receiving 24-hour-a-day home oxygen therapy
Other illness
- 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
- uncontrolled hypertension at screen, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg
- known allergy to 13N Ammonia/82Rubidium or to Regadenoson/Adenosine
- 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)
Lab values
- hemoglobin A1c ≥8.5% at screen
Other
- estimated glomerular filtration rate \<30 ml/min/1.73 m2
- CD4 \<400 cell/mm3
- pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.