Improving Coronary Vascular Health in Women
ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years to 75 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Randomized participants in both groups will be followed for 6 months and then will undergo repeat history, physical, laboratory testing, and repeat cardiac PET/CT scanning."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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) * currently receiving 24-hour-a-day home oxygen therapy
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Markella Zanni, MD · Study contactMore trials in Boston