Improving heart blood flow and angina in women using an SGLT2 pill (STRONG)
Innovative Therapy to Treat Women With Angina With Nonobstructive Coronary Artery Disease (ANOCA) and Coronary Microvascular Disease
PHASE1 · University of Virginia · NCT06600178
This trial will test whether taking the SGLT2 pill Brezavvy for 12 weeks can improve coronary microvascular blood flow and reduce angina symptoms in women with non-obstructive coronary artery disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06600178 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18 or older with anginal symptoms, no obstructive epicardial coronary disease, and a CFR below 2 on CMR who have never taken an SGLT2 inhibitor are ideal candidates.
Not a fit: Patients with obstructive coronary artery disease, reduced LVEF (<40%), heart failure, severe lung or liver disease, recent ACS or recent stroke, or prior SGLT2 inhibitor use are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the treatment could increase myocardial perfusion and reduce angina frequency and severity in women with coronary microvascular dysfunction.
How similar studies have performed: SGLT2 inhibitors have shown cardiovascular benefits in heart failure and diabetes trials, but using them specifically to treat coronary microvascular dysfunction in women is largely novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Angina Patients With Non-obstructive Coronary Artery Disease, Coronary Microvascular Disease, Coronary Microvascular Dysfunction, Angina, ANOCA, Non-obstructive Coronary Artery Disease, CMD, Non-Obstructive CAD