NCT05762952 Effect of Dapagliflozin on Microvascular Function in Women With Symptoms of Coronary Artery Disease
| NCT ID | NCT05762952 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Virginia |
| Condition | Myocardial Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2025-08-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2023-06-06 with a primary completion date of 2025-08-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Patricia Rodriguez-Lozano, MD
PRINCIPAL INVESTIGATOR
University of Virginia Health System
Frequently Asked Questions
Who can join the NCT05762952 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Myocardial Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05762952 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05762952 currently recruiting?
Yes, NCT05762952 is actively recruiting participants. Contact the research team at clf4w@uvahealth.org for enrollment information.
Where is the NCT05762952 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT05762952 clinical trial?
NCT05762952 is sponsored by University of Virginia. The principal investigator is Patricia Rodriguez-Lozano, MD at University of Virginia Health System. The trial plans to enroll 40 participants.