Testing dapagliflozin for heart blood flow improvement in women with ischemic heart symptoms
A Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate Microvascular Disease After 12 Weeks of Therapy With Sodium-glucose Co-transporter 2 Inhibitor Compared to Placebo in Symptomatic Women With Non-obstructive Coronary Artery Disease
This study is testing if the diabetes drug dapagliflozin can improve blood flow in women who have heart symptoms but no blocked arteries.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05762952 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, on coronary blood flow in women experiencing symptoms of myocardial ischemia without obstructive coronary artery disease. Participants will be randomly assigned to receive either dapagliflozin 10mg or a placebo for 12 weeks. The study will assess blood flow using cardiac magnetic resonance imaging at the beginning and end of the treatment period, along with symptom surveys and lab work. The aim is to determine if the drug can improve heart blood flow in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women with symptoms of myocardial ischemia who have been ruled out for obstructive coronary artery disease.
Not a fit: Patients with non-ischemic cardiomyopathy or significant left ventricular dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to improve heart blood flow in women with ischemic heart symptoms.
How similar studies have performed: While studies on dapagliflozin have shown promise in other populations, this specific approach in women with non-obstructive coronary artery disease is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Patricia Rodriguez-Lozano, MD — University of Virginia Health System
- Study coordinator: Caroline L Flournoy, PhD
- Email: clf4w@uvahealth.org
- Phone: 4349246104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.