Improving coronary blood flow in women with HIV and diabetes or chronic kidney disease
ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)
This study will test whether referring women with HIV and diabetes or chronic kidney disease to a specialist so they can be considered for SGLT2 inhibitor medicine, compared with health education alone, improves blood flow in their hearts.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06843902 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women assigned female at birth, age 45–75, living with HIV on stable antiretroviral therapy for ≥180 days, with type 2 diabetes and/or evidence of chronic kidney disease and documented impaired coronary flow on screening PET/CT are ideal candidates.
Not a fit: Patients already taking an SGLT2 inhibitor, with type 1 or ketoacidosis-prone diabetes, a history of myocardial infarction, stroke, heart failure, or without impaired coronary flow on screening are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the approach could improve coronary blood flow in women with HIV and thereby potentially lower their future risk of heart attack.
How similar studies have performed: SGLT2 inhibitors have shown clear cardiovascular and renal benefits in people with diabetes or chronic kidney disease in prior trials, but their effects on coronary microvascular function and in people living with HIV are not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.