NCT06600178RecruitingPhase 1
Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
Innovative Therapy to Treat Women With Angina With Nonobstructive Coronary Artery Disease (ANOCA) and Coronary Microvascular Disease
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 3 Sept 2024
- Start date
- 15 Jul 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- University of Virginia
- Diseases
- Coronary artery disease
- NCT number
- NCT06600178
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 150
- From 15 Jul 2025 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of acute coronary syndrome (ACS) within previous 30 days
Other illness
- History of congestive heart failure, severe pulmonary disease, liver disease
- Stroke within the last 180 days or intracranial hemorrhage at any time.
- Severe valvular disease
- Type 1 diabetes mellitus
- Active malignancy requiring treatment at the time of visit
- History of recurrent UTI/bladder/kidney infections
- 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
- History of reaction to iodinated contrast agents
Lab values
- History of non-ischemic cardiomyopathy LVEF \<40% or hypertrophic cardiomyopathy.
- Severe (eGFR \<30 mL/min/1.73 m2 by CKD-EPI), unstable, or rapidly progressing renal disease at the time of randomization
Age
- Life expectancy \<3 years, due to non-cardiovascular comorbidity.
Other
- Pregnancy or women who are breast-feeding
- Symptomatic hypotension or systolic BP \>95 mmHg on 2 consecutive measurements
- Asthma with ongoing wheezing
- Known intolerance of nitrates (other than hypotension)
Who the study is looking for
- • 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 \< 2 by CMR
- Never on SGLT2i
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UVA Health Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.