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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Angina Patients With Non-obstructive Coronary Artery Disease, Coronary Microvascular Disease, Coronary Microvascular Dysfunction (CMD)

In brief

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

Key facts

Study ID

NCT06600178

Run by

University of Virginia

People needed

150

Starts

2025-06-27

Expected to finish

2026-10-01

Last updated by the study team

2025-10-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• • 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 \&lt; 2 by CMR
• Never on SGLT2i

You may not qualify if…

• 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

Where it is running

• UVA Health — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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