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New treatment option for Myocardial Ischemia
Official title Effect of Dapagliflozin on Microvascular Function in Women With Symptoms of Coronary Artery Disease
ClinicalTrials.gov ID: NCT05762952
What this study is testing
What is Dapagliflozin 10mg Tab?
Dapagliflozin 10mg Tab is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for myocardial ischemia.
Also referred to as active drug.
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 test the effects of a drug (in the drug class called sodium-glucose cotransporter 2 inhibitors) in women who have symptoms of ischemic heart disease. The main questions the study aims to answer are: Does blood flow in the heart improve with study drug?
- 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 to 99, women only
You may be able to join if
- Willing to provide written informed consent.
- Signs and symptoms of suspected ischemia that prompted referral for further evaluation by cardiac catheterization or coronary computed tomography...
- No evidence of obstructive epicardial coronary artery disease (stenosis \>50%) of a major epicardial vessel (\>3mm) or a fractional flow reserve...
- Estimated glomerular filtration rate ≥30ml/min/1.73m2 at enrollment
- For people having a history of type 2 diabetes mellitus: approval of diabetes care/prescribing provider
You likely can't join if
- History of non-ischemic cardiomyopathy with left ventricular ejection fraction \<40% or hypertrophic cardiomyopathy.
- History of congestive heart failure, severe pulmonary disease, liver disease
- History of Acute coronary syndrome 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
- Willing to provide written informed consent.
- Signs and symptoms of suspected ischemia that prompted referral for further evaluation by cardiac catheterization or coronary computed tomography within two years of consent.
- No evidence of obstructive epicardial coronary artery disease (stenosis \>50%) of a major epicardial vessel (\>3mm) or a fractional flow reserve \>0.80 by invasive catheterization or coronary computed tomography...
- Estimated glomerular filtration rate ≥30ml/min/1.73m2 at enrollment
- For people having a history of type 2 diabetes mellitus: approval of diabetes care/prescribing provider
- History of non-ischemic cardiomyopathy with left ventricular ejection fraction \<40% or hypertrophic cardiomyopathy.
- History of congestive heart failure, severe pulmonary disease, liver disease
- History of Acute coronary syndrome 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
- History of diabetic ketoacidosis in people with Type 2 Diabetes Mellitus
- Symptomatic hypotension or systolic blood pressure \<95 mmHg on 2 consecutive measurements
- Active malignancy requiring treatment at the time of visit
- Severe, unstable, or rapidly progressing renal disease at the time of randomization
- History of recurrent urinary tract, bladder, or kidney infections
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 to 99 years. 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.