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

This study is looking at how Brezavvy 20Mg Oral Tablet might help women who have angina (chest pain) and coronary microvascular disease (CMD). CMD means the tiny blood vessels in your heart aren't working as well as they should, even if your main heart arteries are clear. Researchers want to see if Brezavvy can improve blood flow to the heart and reduce angina symptoms and improve quality of life. You might be able to join if you are a woman aged 18 or older with signs of heart ischemia (reduced blood flow) and no major blockages in your heart arteries. The study will measure changes in your coronary flow reserve (CFR), which shows how well your heart can increase blood flow when needed. The study is currently recruiting up to 150 participants.

Study design
This interventional study plans to enroll 150 women. Participants will receive either Brezavvy 20Mg Oral Tablet or a placebo (an inactive tablet).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, change in Coronary Flow Reserve, will be measured from enrollment to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06600178

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

Recruiting
PHASE1Ages 18+InterventionalHealth services
University of Virginia
~150 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:Brezavvy 20Mg Oral TabletPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Coronary Flow Reserve
Measured over From enrollment to 12 weeks

Conditions

Angina Patients With Non-obstructive Coronary Artery Disease
Coronary Microvascular Disease
Coronary Microvascular Dysfunction (CMD)

Explore related trials

AnginaCoronary Microvascular DiseaseNonocclusive coronary artery atherosclerosisColony Stimulating Factor Receptor

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Patricia Rodriguez-Lozano, MD · PRINCIPAL_INVESTIGATOR · Uni

Who to contact

Patricia Rodriguez-Lozano, MD
[email protected]
434-982-1058
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

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

What this trial measures

  • Change in Coronary Flow ReserveFrom enrollment to 12 weeks

    Coronary flow reserve is calculated as the ratio of hyperemic myocardial blood flow to the resting myocardial blood flow using cardiovascular magnetic resonance myocardial perfusion imaging