Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT06600178

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

Led by University of Virginia · Updated on 2025-10-29

150

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age 18 years or older
  • Willing and able to provide written informed consent
  • Signs and symptoms of suspected ischemia leading to cardiac catheterization or coronary CT angiography within 2 years
  • No obstructive epicardial coronary artery disease (stenosis <50%) or FFR ≤0.80 confirmed by catheterization or CT angiography
  • Diagnosis of coronary microvascular disease defined by coronary flow reserve less than 2 by cardiac magnetic resonance imaging
  • Never treated with SGLT2 inhibitors
Not Eligible

You will not qualify if you...

  • History of non-ischemic cardiomyopathy with left ventricular ejection fraction below 40% or hypertrophic cardiomyopathy
  • History of congestive heart failure, severe pulmonary disease, or liver disease
  • Acute coronary syndrome within the past 30 days
  • Stroke within the last 180 days or any prior intracranial hemorrhage
  • Severe valvular heart disease
  • Life expectancy less than 3 years due to non-cardiovascular illness
  • Pregnancy or breastfeeding
  • Type 1 diabetes mellitus
  • Symptomatic low blood pressure or systolic blood pressure less than 95 mmHg on two readings
  • Active cancer requiring treatment
  • Severe or unstable kidney disease with eGFR below 30 mL/min/1.73 m2
  • History of recurrent urinary tract or kidney infections
  • Asthma with ongoing wheezing
  • Known or suspected bronchospastic lung diseases such as ARDS or emphysema
  • Heart block beyond first degree
  • Implanted cardiac device
  • Very slow heart rate below 40 beats per minute
  • Atrial fibrillation or supraventricular arrhythmias during imaging
  • Intolerance to nitrates (except hypotension)
  • History of reaction to iodinated contrast agents

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UVA Health

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

P

Patricia Rodriguez-Lozano, MD

CONTACT

S

Shuo Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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