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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Virginia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenzavvy (bexagliflozin), 20 mg Oral Tablet

    Drug

    Brenzavvy (bexagliflozin), 20 mg Oral Tablet

  • Placebo

    Drug

    Placebo tablet given to subject vs. active drug.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Active Drug GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Coronary Flow Reserve

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

Time frame
From enrollment to 12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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