RECRUITING Phase 1 ClinicalTrials.gov

Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)

Sponsor: University of Virginia • ClinicalTrials.gov ID: NCT06600178

Registry updated: 2026-09-09

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Description

The goal of this clinical trial is to that Sodium-glucose cotransporter 2 inhibitors treatment will improve Coronary Microvascular Disease with anginal symptoms associated with non-obstructive coronary disease in women. The main questions it aims to answer are: Aim 1: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves coronary microvascular disease in women with no evidence of epicardial obstructive coronary artery disease. Aim 2: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves angina symptoms and other quality of life measurements associated with the improvement of CFR. AIM 3: Identify the effect of Sodium-glucose cotransporter 2 inhibition on inflammation pathways and markers of systemic Research will compare Brezavvy to placebo Participants will: * Take study drug or placebo for 12 weeks * Stress Cardiac magnetic resonance imaging * 12 lead electrocardiograms * Complete questionnaires

Interventions

Brenzavvy (bexagliflozin), 20 mg Oral Tablet (Drug)
Brenzavvy (bexagliflozin), 20 mg Oral Tablet
Placebo (Drug)
Placebo tablet given to subject vs. active drug.

Eligibility criteria

Inclusion Criteria: * • Female sex. * Age ≥18 years. * Willing and able to provide written informed consent. * Signs and symptoms of suspected ischemia prompted referral for further evaluation by cardiac catheterization or CCTA within two years of consent. * No evidence of obstructive epicardial CAD (stenosis \<50%) of a major epicardial vessel or an FFR ≤0.80 by invasive catheterization or CCTA. Patients who have not undergone cardiac catheterization of CT angiogram within the last 2 years for chest pain can be scheduled for a screening CT angiogram of the coronary arteries to confirm eligibility. * Diagnosis of CMD defined by CFR \< 2 by CMR * Never on SGLT2i Exclusion Criteria: * History of non-ischemic cardiomyopathy LVEF \<40% or hypertrophic cardiomyopathy. * History of congestive heart failure, severe pulmonary disease, liver disease * History of acute coronary syndrome (ACS) within previous 30 days * Stroke within the last 180 days or intracranial hemorrhage at any time. * Severe valvular disease * Life expectancy \<3 years, due to non-cardiovascular comorbidity. * Pregnancy or women who are breast-feeding * Type 1 diabetes mellitus * Symptomatic hypotension or systolic BP \>95 mmHg on 2 consecutive measurements * Active malignancy requiring treatment at the time of visit * Severe (eGFR \<30 mL/min/1.73 m2 by CKD-EPI), unstable, or rapidly progressing renal disease at the time of randomization * History of recurrent UTI/bladder/kidney infections * Asthma with ongoing wheezing * Known or suspected broncho-constrictive or bronchospastic lung disease (ARDS, emphysema) * Greater than first degree heart block * Implanted cardiac device * Profound sinus bradycardia (heart rate \<40 beats per minute) * Atrial fibrillation or supraventricular arrhythmias at time of imaging * Known intolerance of nitrates (other than hypotension) * History of reaction to iodinated contrast agents

Conditions

Angina Patients With Non-obstructive Coronary Artery Disease Coronary Microvascular Disease Coronary Microvascular Dysfunction (CMD)

Locations

UVA Health — Charlottesville, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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