NCT06600178 · University of Virginia
Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
(STRONG)
What this study is about
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.
View original scientific 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.
Interventions
DRUG
Brezavvy 20Mg Oral Tablet
Brezavvy 20mg oral
DRUG
Placebo
Placebo tablet given to subject vs. active drug.
Primary outcome measures
Change in Coronary Flow Reserve
Time frame: From enrollment to 12 weeks
Coronary flow reserve is calculated as the ratio of hyperemic myocardial blood flow to the resting myocardial blood flow using cardiovascular magnetic resonance myocardial perfusion imaging
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Charlottesville, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations