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

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 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 \&lt; 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

Conditions4

Locations1 site

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