RECRUITING

Improving Coronary Vascular Health in Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)

Quick Facts

Study Start:2025-04-17
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06843902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * female sex-at-birth
  2. * self-report of HIV on stable anitretroviral therapy ≥180 days
  3. * age 45 -75 years
  4. * 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
  5. * coronary flow reserve \<2.5 on screening cardiac positron emission tomography/computed tomography
  1. * current SGLT2 inhibitor use
  2. * known allergy to SGLT2 inhibitor use
  3. * type 1 diabetes or ketoacidosis prone diabetes (diabetes with a history of ketoacidosis)
  4. * self-reported history of polycystic kidney disease
  5. * self-reported history of myocardial infarction, stroke, or coronary revascularization
  6. * stable or unstable angina
  7. * self-reported history of heart failure
  8. * hemoglobin A1c ≥8.5% at screen
  9. * uncontrolled hypertension at screen, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg
  10. * estimated glomerular filtration rate \<30 ml/min/1.73 m2
  11. * currently receiving hemodialysis or peritoneal dialysis
  12. * CD4 \<400 cell/mm3
  13. * 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
  14. * pregnancy or breastfeeding
  15. * known allergy to 13N Ammonia/82Rubidium or to Regadenoson/Adenosine
  16. * concurrent enrollment in conflicting research study

Contacts and Locations

Study Contact

Sarah Chu, NP
CONTACT
617-724-6091
schu4@mgh.harvard.edu

Principal Investigator

Markella V Zanni, MD
PRINCIPAL_INVESTIGATOR
MGH/HMS

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Markella V Zanni, MD, PRINCIPAL_INVESTIGATOR, MGH/HMS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-17
Study Completion Date2029-06

Study Record Updates

Study Start Date2025-04-17
Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • women
  • diabetes
  • chronic kidney disease
  • SGLT2 inhibitor therapy
  • coronary flow reserve
  • cardiovascular disease prevention

Additional Relevant MeSH Terms

  • HIV-1-infection
  • Coronary Microvascular Dysfunction
  • Metabolic Disease