Improving Coronary Vascular Health in Women

Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Improving Coronary Vascular Health in Women," is focused on understanding how to improve heart health in women living with HIV. Women with HIV are at a higher risk of having heart attacks compared to those without HIV, and this study aims to explore whether a specific type of medication, called SGLT2 inhibitors, can help improve blood flow in their hearts. Participants in the trial will be women aged 45 to 75 who have HIV and either type 2 diabetes or chronic kidney disease. They will be randomly assigned to either receive health education alone or health education along with a referral to a specialist who may prescribe the SGLT2 inhibitors.

To be eligible for the study, participants must be female, have been on stable HIV treatment for at least six months, and meet certain health criteria related to their diabetes or kidney function. Those who join the trial can expect to receive support and education about their health, and some may have the opportunity to try the SGLT2 medication. The study is not yet recruiting participants, but it is important for women with HIV and these health conditions to know that research is being conducted to better understand and improve their heart health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • female sex-at-birth
• • self-report of HIV on stable anitretroviral 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 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