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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06600178
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brezavvy 20Mg Oral Tablet — DRUG
    Brezavvy 20mg oral
  • Placebo — DRUG
    Placebo tablet given to subject vs. active drug.

Study Details

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

Key Dates

Start date
Jun 27, 2025
Status verified
Mar 2025
Primary completion
Mar 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Active Drug Group
    Brezavvy 20mg oral tablet
  • Placebo Comparator: Placebo Group
    placebo tablet

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UVA HealthCharlottesvilleVirginia22908
Shuo Wang
[email protected]
4349821058
Nicole Sprouse, RN
[email protected]
434-982-1058

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By research site
UVA Health· Charlottesville, VA

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