HIV-1-infectionPhase 2INFORM_2NCT06843902
Improving Coronary Vascular Health in Women
A Phase 2 study testing Health Education and Subspecialty clinic referral in people with HIV-1-infection and Coronary Microvascular Dysfunction, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- HIV-1-infection, Coronary Microvascular Dysfunction, Metabolic Disease
- What is being tested?
- Health Education and Subspecialty clinic referral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Markella Zanni, MD
About this study
Official title: ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)
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.
Read the detailed 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. Prior to randomization, to confirm eligibility, participants will have undergone history, physical, lab tests, and cardiac positron emission tomography/computed tomography (PET/CT) scanning to confirm that there is a measure of impairment in stimulated blood flow through the large and small arteries of the heart. 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. 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. We will also investigate effects of SGLT inhibitor therapy (and, separately, of subspecialty clinic referral) on fat tissue around the heart, as well as on blood and urine-based markers of metabolic disease and inflammation.
- Being tested
- Health Education, Subspecialty clinic referral
- Keywords
- HIV, women, diabetes, chronic kidney disease, SGLT2 inhibitor therapy, coronary flow reserve, cardiovascular disease prevention
- Medical subject headings
- Metabolic Diseases, Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationOther
Health Education
Subspecialty clinic referralOther
This intervention will entail referred to establish clinical care in either the MGH Lipid and Metabolism Clinic or the MGH Renal Clinic for consideration of SGLT2 inhibitor therapy. SGLT2 inhibitor therapy (e.g. empagliflozin 10 mg by mouth daily or dapagliflozin 10 mg by mouth daily) may or may not be prescribed by the subspecialty clinician as part of routine clinical care, according to the clinician's clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Health education plus subspecialty clinic referral for consideration of SGLT2 inhibitor therapy | Experimental | Participants randomized to this study arm will receive health education and will be referred to establish clinical care in either the MGH Lipid and Metabolism Clinic or the MGH Renal Clinic for consideration of SGLT2 inhibitor therapy. By study design (inclusion criteria), participants will have a clinical indication for SGLT2 inhibitor therapy (either diabetes or chronic kidney disease). SGLT2 inhibitor therapy (e.g. empagliflozin 10 mg by mouth daily or dapagliflozin 10 mg by mouth daily) may or may not be prescribed by the subspecialty clinician as part of routine clinical care, according to the clinician's clinical judgement. Participants will also receive health education. Receives: Other: Health Education |
| Health Education | Other | Participants randomized to this study arm will receive health education alone. Receives: Other: Health Education; Other: Subspecialty clinic referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow Reserve
Change in coronary flow reserve by cardiac positron emission tomography
Measured: 24 weeks
Ectopic Adipose Tissue
Change in ectopic adipose tissue reserve by cardiac computed tomography
Measured: 24 weeks
Secondary outcomes (4)
Kidney-related biomarkers
Urine and serum biomarkers related to kidney health and disease
Measured: 24 weeks
Metabolic biomarkers
Urine and serum biomarkers relating to metabolism (including glucose and lipid metabolism)
Measured: 24 weeks
Immune/inflammatory biomarkers
Urine and serum biomarkers relating to inflammation and immune activation
Measured: 24 weeks
HIV-specific parameters
Serum variables relating to HIV disease (such as HIV-1 viral load, CD4 T cell count, CD8 T cell count)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start17 Apr 2025
- Primary completionMar 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Markella V. Zanni,M.D., Massachusetts General Hospital
- Investigators
- Markella V Zanni, MD, Principal investigator, MGH/HMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843902
- Sponsor's protocol ID
- 2024P001952
- Other IDs
- R01HL170905
- Acronym
- INFORM_2
- Status last verified
- Oct 2025
- First submitted
- 19 Feb 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plans are for IPD to be shared to the NIH BioLINCC data repository.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)
- ClinicalTrials.gov ID
- NCT06843902
- Acronym / sponsor ID
- INFORM_2 / 2024P001952
- Keywords
- HIV, women, diabetes, chronic kidney disease, SGLT2 inhibitor therapy, coronary flow reserve, cardiovascular disease prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. Prior to randomization, to confirm eligibility, participants will have undergone history, physical, lab tests, and cardiac positron emission tomography/computed tomography (PET/CT) scanning to confirm that there is a measure of impairment in stimulated blood flow through the large and small arteries of the heart. 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. 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. We will also investigate effects of SGLT inhibitor therapy (and, separately, of subspecialty clinic referral) on fat tissue around the heart, as well as on blood and urine-based markers of metabolic disease and inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health education plus subspecialty clinic referral for consideration of SGLT2 inhibitor therapy | Experimental | Other: Health EducationParticipants randomized to this study arm will receive health education and will be referred to establish clinical care in either the MGH Lipid and Metabolism Clinic or the MGH Renal Clinic for consideration of SGLT2 inhibitor therapy. By study design (inclusion criteria), participants will have a clinical indication for SGLT2 inhibitor therapy (either diabetes or chronic kidney disease). SGLT2 inhibitor therapy (e.g. empagliflozin 10 mg by mouth daily or dapagliflozin 10 mg by mouth daily) may or may not be prescribed by the subspecialty clinician as part of routine clinical care, according to the clinician's clinical judgement. Participants will also receive health education. |
| Health Education | Other | Other: Health Education, Other: Subspecialty clinic referralParticipants randomized to this study arm will receive health education alone. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationHealth Education | Other | Health Education, Health education plus subspecialty clinic referral for consideration of SGLT2 inhibitor therapy |
| Subspecialty clinic referralThis intervention will entail referred to establish clinical care in either the MGH Lipid and Metabolism Clinic or the MGH Renal Clinic for consideration of SGLT2 inhibitor therapy. SGLT2 inhibitor therapy (e.g. empagliflozin 10 mg by mouth daily or dapagliflozin 10 mg by mouth daily) may or may not be prescribed by the subspecialty clinician as part of routine clinical care, according to the clinician's clinical judgement. | Other | Health Education |
Primary outcome
Coronary Flow Reserve
Time frame: 24 weeks
Change in coronary flow reserve by cardiac positron emission tomography
Ectopic Adipose Tissue
Time frame: 24 weeks
Change in ectopic adipose tissue reserve by cardiac computed tomography
4 secondary outcomes
Kidney-related biomarkers
Time frame: 24 weeks
Metabolic biomarkers
Time frame: 24 weeks
Immune/inflammatory biomarkers
Time frame: 24 weeks
HIV-specific parameters
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Plans are for IPD to be shared to the NIH BioLINCC data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markella V Zanni, MD principal investigator
MGH/HMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Health Education and Subspecialty clinic referral in people with HIV-1-infection and Coronary Microvascular Dysfunction, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Chu, NP (617-724-6091, schu4@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Flow Reserve (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.