Improving heart blood flow and angina in women using an SGLT2 pill (STRONG)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial gives women with angina and non-obstructive coronary artery disease either Brezavvy or a matching placebo for 12 weeks and compares results. Participants undergo stress cardiac MRI to measure coronary flow reserve (CFR), 12-lead ECGs, blood tests for inflammatory markers, and symptom and quality-of-life questionnaires. Eligible participants are adult women with CFR <2 by CMR and no obstructive epicardial coronary disease, and they must not have prior SGLT2 inhibitor use. The study is conducted at UVA Health in Charlottesville with scheduled imaging and clinic visits for treatment and follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• UVA Health
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Patricia Rodriguez-Lozano, MD — Uni
• Study coordinator: Patricia Rodriguez-Lozano, MD
• Email: PR3GG@uvahealth.org
• Phone: 434-982-1058

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.