Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease (ENTRY Trial)

CHEOL WHAN LEE, M.D., Ph.D1 site in 1 country2 target enrollmentMay 21, 2020

ConditionsCoronary Artery Disease Prediabetic State

InterventionsDapagliflozin 10mg Lifestyle modification

DrugsDapagliflozin 10mg

Overview

Phase: Phase 4
Intervention: Dapagliflozin 10mg
Conditions: Coronary Artery Disease
Sponsor: CHEOL WHAN LEE, M.D., Ph.D
Enrollment: 2
Locations: 1
Primary Endpoint: Percent change in global myocardial perfusion reserve (MPR) index
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (MPR) using dynamic SPECT examination in prediabetic patients with stable CAD.

Dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable CAD.

Registry

clinicaltrials.gov

Start Date

May 21, 2020

End Date

April 8, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CHEOL WHAN LEE, M.D., Ph.D

Responsible Party

Sponsor Investigator

Principal Investigator

CHEOL WHAN LEE, M.D., Ph.D

Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

•Men or women at least 18 years of age
•Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
•Stable coronary artery disease
•Global myocardial perfusion reserve (MPR) index \< 2.0
•The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria

•Contraindications to dapagliflozin
•Significant renal disease manifested by eGFR\<30 ml/min/1.73m²
•Unstable or rapidly progressing renal disease
•Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
•Stent placement, or coronary artery bypass graft surgery within the previous 6 months
•Planned revascularization within 6 months
•Significant disease (diameter stenosis \>70% by coronary CT angiography) in major epicardial coronary arteries
•Heart failure requiring loop diuretics
•Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
•Contraindication to adenosine stress test