NCT05762952RecruitingPhase 1
Effect of Dapagliflozin on Microvascular Function in Women With Symptoms of Coronary Artery Disease
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Jan 2023
- Start date
- 6 Jun 2023
- Primary completion date
- 5 Aug 2025
- Lead sponsor
- University of Virginia
- Diseases
- Coronary artery disease
- NCT number
- NCT05762952
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 6 Jun 2023 to the primary completion date, 5 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of Acute coronary syndrome within previous 30 days
Other illness
- History of congestive heart failure, severe pulmonary disease, liver disease
- Stroke within the last 180 days or intracranial hemorrhage at any time.
- Severe Valvular disease
- Type 1 diabetes mellitus
- History of diabetic ketoacidosis in subjects with Type 2 Diabetes Mellitus
- 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
Lab values
- History of non-ischemic cardiomyopathy with left ventricular ejection fraction \<40% or hypertrophic cardiomyopathy.
Age
- Life expectancy \<3 years, due to non-cardiovascular comorbidity.
Other
- Pregnancy or women who are breast-feeding
- Symptomatic hypotension or systolic blood pressure \<95 mmHg on 2 consecutive measurements
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.