RECRUITING

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

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Conditions

Myocardial Ischemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-06
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05762952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing to provide written informed consent.
  2. * Signs and symptoms of suspected ischemia that prompted referral for further evaluation by cardiac catheterization or coronary computed tomography within two years of consent.
  3. * 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).
  4. * Estimated glomerular filtration rate ≥30ml/min/1.73m2 at enrollment
  5. * For subjects having a history of type 2 diabetes mellitus: approval of diabetes care/prescribing provider
  1. * History of non-ischemic cardiomyopathy with left ventricular ejection fraction \<40% or hypertrophic cardiomyopathy.
  2. * History of congestive heart failure, severe pulmonary disease, liver disease
  3. * History of Acute coronary syndrome within previous 30 days
  4. * Stroke within the last 180 days or intracranial hemorrhage at any time.
  5. * Severe Valvular disease
  6. * Life expectancy \<3 years, due to non-cardiovascular comorbidity.
  7. * Pregnancy or women who are breast-feeding
  8. * Type 1 diabetes mellitus
  9. * History of diabetic ketoacidosis in subjects with Type 2 Diabetes Mellitus
  10. * Symptomatic hypotension or systolic blood pressure \<95 mmHg on 2 consecutive measurements
  11. * Active malignancy requiring treatment at the time of visit
  12. * Severe, unstable, or rapidly progressing renal disease at the time of randomization
  13. * History of recurrent urinary tract, bladder, or kidney infections

Contacts and Locations

Study Contact

Caroline L Flournoy, PhD
CONTACT
4349246104
clf4w@uvahealth.org

Principal Investigator

Caroline L Flournoy, MD
PRINCIPAL_INVESTIGATOR
University of Virginia Health System

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Caroline L Flournoy, MD, PRINCIPAL_INVESTIGATOR, University of Virginia Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-06-06
Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Myocardial Ischemia