About this trial
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?
Participants will be randomly assigned to a 12-week course of the study drug, dapagliflozin 10mg, or placebo. Blood flow in the heart will be assessed using stress cardiac magnetic resonance imaging at baseline and 12 weeks. The researchers will compare the results from the two groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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. (Participants who have not undergone cardiac catheterization or coronary angiogram within the last 2 years for their clinical care will be screened with computed angiogram of the coronary arteries to confirm eligibility).
Estimated glomerular filtration rate ≥30ml/min/1.73m2 at enrollment
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Dapagliflozin 10mg Tab
DrugOnce daily oral dapagliflozin 10mg
Placebo
DrugPlacebo capsules formulated by pharmacy to be indistinguishable from active drug
Treatment groups
Trial outcomes
Primary outcomes
Change in myocardial perfusion reserve
Myocardial microvascular perfusion, defined as myocardial perfusion reserve as assessed by stress cardiac magnetic resonance imaging
Sponsors and contacts
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