Effect of Dapagliflozin on Microvascular Function in Women With Symptoms of Coronary Artery Disease

Launched by UNIVERSITY OF VIRGINIA · Feb 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called dapagliflozin affects blood flow in the heart of women who have symptoms of coronary artery disease, a condition that can cause chest pain or discomfort when the heart doesn't get enough blood. The main goal is to see if this drug can improve heart blood flow over a 12-week period compared to a placebo, which is a harmless substance with no active medication. Participants will undergo a special heart imaging test before and after the treatment to see if there are any changes.

To participate, women aged 36 to 74 who have symptoms suggesting their heart might not be getting enough blood flow may be eligible. However, they must not have significant blockages in their heart arteries and should have normal kidney function. During the study, participants will be randomly assigned to receive either the study drug or a placebo, and they will be monitored closely throughout the trial. This study is currently recruiting participants, and it’s important for interested individuals to discuss their health history and any medications with their healthcare provider to determine if they qualify.

Gender

FEMALE

Eligibility criteria

• Inclusion 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. (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
• • For subjects having a history of type 2 diabetes mellitus: approval of diabetes care/prescribing provider
• Exclusion Criteria:
• • 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 subjects 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