Status:
RECRUITING
Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
Lead Sponsor:
University of Virginia
Conditions:
Angina Patients With Non-obstructive Coronary Artery Disease
Coronary Microvascular Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 coronar...
Detailed Description
Cardio microvascular disease is defined as epicardial and/or microvascular endothelial and/or non-endothelial dysfunction that limits myocardial perfusion, most often detected as reduced coronary flow...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06600178
Start Date
June 27 2025
End Date
October 1 2026
Last Update
October 29 2025
Active Locations (1)
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1
UVA Health
Charlottesville, Virginia, United States, 22908