Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
Innovative Therapy to Treat Women With Angina With Nonobstructive Coronary Artery Disease (ANOCA) and Coronary Microvascular Disease
University of Virginia
150 participants
Jun 27, 2025
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria7
- 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 Criteria20
- 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
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Interventions
Brezavvy 20mg oral
Placebo tablet given to subject vs. active drug.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06600178