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

Study 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.

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

Conditions
-----------------
Coronary Artery Disease, Prediabetic State

Intervention / Treatment
-----------------
* Drug: Dapagliflozin 10mg
* Other: Lifestyle modification


Participation Criteria
=================
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 Current treatment for the active cancer Women of child bearing potential who are not willing to use a medically accepted method of contraception. Patient's pregnancy confirmed by positive pregnancy test, or breast-feeding. Expected life expectancy < 1 year Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests which, in the judgment of the investigator, would preclude safe completion of the study. Unwillingness or inability to comply with the procedures described in this protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin<br> | Drug: Dapagliflozin 10mg<br>* Dapagliflozin 10mg once daily for 6 months.<br>|
| Other: Lifestyle modification<br> | Other: Lifestyle modification<br>* lifestyle modification (diet and exercise) for 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in global myocardial perfusion reserve (MPR) index |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in regional myocardial perfusion reserve (MPR) index |  | 6months | 
| absolute changes in global MPR index |  | 6months | 
| absolute changes in regional MPR index |  | 6months | 
| Change in body weight |  | 6months | 
| Change in blood pressure(systolic, diastolic both ) |  | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dapagliflozin, Lifestyle modification, Myocardial perfusion reserve