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Dapagliflozin for Microvascular Function in Women with Chest Pain

This study is looking at whether dapagliflozin 10mg, a daily pill, can improve blood flow in the hearts of women who have symptoms of heart disease (myocardial ischemia) but do not have blockages in their main heart arteries. You may be eligible if you are a woman between 18 and 99 years old, have symptoms of suspected ischemia, and have had tests within the last two years that ruled out significant blockages in your heart arteries. The main goal is to see if dapagliflozin improves blood flow in the heart after 12 weeks of treatment. The study status is currently unclear, and it plans to enroll 40 participants.

Study design
This is a randomized, double-blind, placebo-controlled study involving 40 women. Participants will be randomly assigned to receive either dapagliflozin 10mg or a placebo.
What's involved
You would take dapagliflozin 10mg or a placebo daily for 12 weeks. You will have assessments at the start, at 6 weeks, and at 12 weeks, including stress cardiac magnetic resonance imaging (MRI) at the beginning and end of the 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored throughout the 12 weeks of treatment, with the primary endpoint measured at 12 weeks.

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NCT05762952

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

Recruiting
PHASE1Ages 18–99InterventionalTreatment
University of Virginia
~40 participants
Updated 2025-08-22 on ClinicalTrials.gov
What's tested:Dapagliflozin 10mg TabPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in myocardial perfusion reserve
Measured over Baseline and after 12 weeks of treatment

Conditions

Myocardial Ischemia

Explore related trials

Ischemic Heart Disease

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Patricia Rodriguez-Lozano, MD · PRINCIPAL_INVESTIGATOR · University of Virginia Health System

Who to contact

Caroline L Flournoy, PhD
[email protected]
4349246104
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in myocardial perfusion reserveBaseline and after 12 weeks of treatment

    Myocardial microvascular perfusion, defined as myocardial perfusion reserve as assessed by stress cardiac magnetic resonance imaging