Actively Recruiting
ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)
Led by Massachusetts General Hospital · Updated on 2025-10-15
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Women with HIV face a higher risk of heart attacks compared to women without HIV, possibly due to reduced blood flow through the heart's large and small arteries when extra oxygen is needed. This study is a Phase 2 trial evaluating if treatment with sodium glucose transporter 2 (SGLT2) inhibitors, alongside specialty clinic referrals, can improve blood flow in women with HIV who also have diabetes, chronic kidney disease, or both, but no history of heart attack. The research is sponsored by Massachusetts General Hospital to better understand cardiovascular health in this group. Participants are randomly assigned to one of two groups: one receives health education plus a referral to an endocrinology or nephrology clinic for possible SGLT2 inhibitor therapy, while the other receives health education alone. The medication, such as empagliflozin or dapagliflozin taken daily by mouth, may be prescribed based on clinical judgment. The study lasts six months, with both groups undergoing initial and repeat cardiac PET/CT scans, physical exams, labs, and clinical assessments. Women will be involved in detailed evaluations including history, physical exams, blood and urine testing, and advanced heart imaging to measure coronary flow reserve and fat around the heart. Researchers will assess changes in heart blood flow and metabolic, kidney, immune, and HIV-related biomarkers after 24 weeks. The study also monitors safety and treatment adherence, with the total participation time covering initial screening and six months of follow-up.
CONDITIONS
Brief Title
Improving Coronary Vascular Health in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex at birth
- Age between 45 and 75 years
- Self-report of HIV on stable antiretroviral therapy for at least 180 days
- Diagnosis of at least one of the following: type 2 diabetes mellitus, estimated glomerular filtration rate 30-60 ml/min/1.73 m2, or urine albumin to creatinine ratio greater than 30 mg/g
- Coronary flow reserve less than 2.5 or stress myocardial blood flow less than 2.5 on screening cardiac PET/CT scan
You will not qualify if you...
- Current use of SGLT2 inhibitor medication
- Known allergy to SGLT2 inhibitors
- Type 1 diabetes or diabetes prone to ketoacidosis
- History of polycystic kidney disease
- History of myocardial infarction, stroke, or coronary revascularization
- Stable or unstable angina
- History of heart failure
- Hemoglobin A1c greater than or equal to 8.5% at screening
- Uncontrolled hypertension (systolic blood pressure 180 mm Hg or higher and/or diastolic blood pressure 110 mm Hg or higher)
- Estimated glomerular filtration rate below 30 ml/min/1.73 m2
- Currently receiving hemodialysis or peritoneal dialysis
- CD4 count less than 400 cells/mm3
- Current treatment with systemic steroids or immune suppressant therapies (excluding topical, UV, aspirin derivatives, or NSAIDs)
- Pregnancy or breastfeeding
- Known allergy to 13N Ammonia, 82Rubidium, Regadenoson, or Adenosine
- Concurrent enrollment in a conflicting research study
- History of recurrent urinary tract infections or vaginal yeast infections as specified in the criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive health education and may be referred to a subspecialty clinic for consideration of SGLT2 inhibitor therapy as part of routine clinical care, or receive health education alone.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Sarah Chu, NP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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