Recruiting
Phase 1

Dapagliflozin

Sponsor:

University of Virginia

Code:

NCT05762952

Conditions

Myocardial Ischemia

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin 10mg Tab

Placebo

Study Details

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.

Conditions

Myocardial Ischemia

Study ID

NCT05762952

Start date

Jun 6, 2023

Status verified date

Mar, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Aug 5, 2025

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dapagliflozin

Dapagliflozin 10mg oral tablet.

placebo comparator: Placebo

Placebo matching tablet.

Interventions

Dapagliflozin 10mg Tab

Once daily oral dapagliflozin 10mg

Placebo

Placebo capsules formulated by pharmacy to be indistinguishable from active drug

Primary outcome measure

  • Change in myocardial perfusion reserve [ Time Frame: Baseline and after 12 weeks of treatment ]

Central Contacts and Locations

Central contacts

Caroline L Flournoy, PhD

4349246104clf4w@uvahealth.org

Nicole J Sprouse, RN

434-982-1058njb6m@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Caroline L Flournoy

4349246104clf4w@uvahealth.org

Principal Investigator:

Patricia Rodrguez, MD

More Information

Sponsor

University of Virginia

Last update posted

Aug 22, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-08-22.