BridgeMD
New treatment option for Angina Patients With Non-obstructive Coronary Artery Disease
Official title Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
ClinicalTrials.gov ID: NCT06600178
What this study is testing
What is Brezavvy 20Mg Oral Tablet?
Brezavvy 20Mg Oral Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for angina patients with non-obstructive coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- Diagnosis of CMD defined by CFR \< 2 by CMR
- Never on SGLT2i
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.