NCT06600178 Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
| NCT ID | NCT06600178 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Virginia |
| Condition | Angina Patients With Non-obstructive Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2025-07-15 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Patricia Rodriguez-Lozano, MD
PRINCIPAL INVESTIGATOR
Uni
Frequently Asked Questions
Who can join the NCT06600178 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Angina Patients With Non-obstructive Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06600178 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06600178 currently recruiting?
Yes, NCT06600178 is actively recruiting participants. Contact the research team at PR3GG@uvahealth.org for enrollment information.
Where is the NCT06600178 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06600178 clinical trial?
NCT06600178 is sponsored by University of Virginia. The principal investigator is Patricia Rodriguez-Lozano, MD at Uni. The trial plans to enroll 150 participants.