Recruiting
Phase 1

SGLT2 Inhibitors

Sponsor:

University of Virginia

Code:

NCT06600178

Conditions

Angina Patients With Non-obstructive Coronary Artery Disease

Coronary Microvascular Disease

Coronary Microvascular Dysfunction (CMD)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brenzavvy (bexagliflozin), 20 mg Oral Tablet

Placebo

Study Details

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

Conditions

Angina Patients With Non-obstructive Coronary Artery Disease

Coronary Microvascular Disease

Coronary Microvascular Dysfunction (CMD)

Study ID

NCT06600178

Start date

Jul 15, 2025

Status verified date

Sep, 2026

Completion date

Jun 29, 2029

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Active Drug Group

Brenzavvy (bexagliflozin), 20 mg Oral Tablet

placebo comparator: Placebo Group

placebo tablet

Interventions

Brenzavvy (bexagliflozin), 20 mg Oral Tablet

Brenzavvy (bexagliflozin), 20 mg Oral Tablet

Placebo

Placebo tablet given to subject vs. active drug.

Primary outcome measure

  • Change in Coronary Flow Reserve [ Time Frame: From enrollment to 12 weeks ]

Central Contacts and Locations

Central contacts

Patricia Rodriguez-Lozano, MD

434-982-1058PR3GG@uvahealth.org

Shuo Wang

4349821058VJR7CE@uvahealth.org

Locations

UVA Health

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Shuo Wang

4349821058VJR7CE@uvahealth.org

Nicole Sprouse, RN

434-982-1058njb6m@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Angina
  • ANOCA
  • Non-obstructive Coronary Artery Disease
  • CMD
  • Non-Obstructive CAD
  • Chest Pain in Women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-09-09.