Actively Recruiting

Phase 1
Age: 18Years - 99Years
FEMALE
NCT05762952

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

Led by University of Virginia · Updated on 2025-08-22

40

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to provide written informed consent.
  • Signs and symptoms of suspected ischemia that led to cardiac catheterization or coronary CT within 2 years.
  • No obstructive coronary artery disease (stenosis >50%) or fractional flow reserve >0.80 by invasive catheterization or coronary CT.
  • Estimated glomerular filtration rate of 30 ml/min/1.73m2 or higher at enrollment.
  • If history of type 2 diabetes, approval from diabetes care provider.
Not Eligible

You will not qualify if you...

  • History of non-ischemic cardiomyopathy with left ventricular ejection fraction less than 40% or hypertrophic cardiomyopathy.
  • History of congestive heart failure, severe pulmonary disease, or liver disease.
  • Acute coronary syndrome within the past 30 days.
  • Stroke within the last 180 days or any past intracranial hemorrhage.
  • Severe valvular heart disease.
  • Life expectancy less than 3 years due to non-cardiovascular illness.
  • Pregnancy or breastfeeding.
  • Type 1 diabetes mellitus.
  • History of diabetic ketoacidosis in type 2 diabetes.
  • Symptomatic low blood pressure or systolic blood pressure below 95 mmHg on two measurements.
  • Active cancer needing treatment at the time of study.
  • Severe, unstable, or rapidly worsening kidney disease.
  • History of repeated urinary tract, bladder, or kidney infections.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

C

Caroline L Flournoy, PhD

CONTACT

N

Nicole J Sprouse, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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