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NCT06843902 · ClinicalTrials.gov registry record · Phase 2
Improving Coronary Vascular Health in Women
A Phase 2 study of HIV-1-infection and Metabolic Disease, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06843902: Recruiting Phase 2 study of HIV-1-infection and Metabolic Disease, sponsored by Massachusetts General Hospital.
NCT06843902 is a Phase 2 study of HIV-1-infection and Metabolic Disease that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 80 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06843902, a Phase 2 study of HIV-1-infection and Metabolic Disease, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Change in coronary flow reserve by cardiac positron emission tomography
Conditions Studied
Interventions
- OTHER Health Education
- OTHER Subspecialty clinic referral
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
What NCT06843902 shows while recruiting
NCT06843902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which Health Education is the first listed.
NCT06843902 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06843902 about?
NCT06843902 is a clinical study titled "Improving Coronary Vascular Health in Women". 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 corona...
What is the current status of trial NCT06843902?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2025-04-17. Estimated completion is 2029-06.
What conditions does trial NCT06843902 study?
This clinical trial studies the following conditions: HIV-1-infection, Metabolic Disease, Coronary Microvascular Dysfunction.
What interventions are being tested in trial NCT06843902?
The interventions under investigation include: Health Education (OTHER), Subspecialty clinic referral (OTHER).
Who is sponsoring clinical trial NCT06843902?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06843902 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06843902's enrollment target sits among peer trials
80 36th of 71 higher than 36 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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