Coronary Artery Disease, Prediabetic State
Conditions
Keywords
Dapagliflozin, Lifestyle modification, Myocardial perfusion reserve
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.
Interventions
DRUGDapagliflozin 10mg
Dapagliflozin 10mg once daily for 6 months.
OTHERLifestyle modification
lifestyle modification (diet and exercise) for 6 months
Sponsors
CHEOL WHAN LEE, M.D., Ph.D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women at least 18 years of age 2. Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%) 3. Stable coronary artery disease 4. Global myocardial perfusion reserve (MPR) index \< 2.0 5. 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
1. Contraindications to dapagliflozin 2. Significant renal disease manifested by eGFR\<30 ml/min/1.73m² 3. Unstable or rapidly progressing renal disease 4. Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months 5. Stent placement, or coronary artery bypass graft surgery within the previous 6 months 6. Planned revascularization within 6 months 7. Significant disease (diameter stenosis \>70% by coronary CT angiography) in major epicardial coronary arteries 8. Heart failure requiring loop diuretics 9. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal). 10. Contraindication to adenosine stress test 11. Current treatment for the active cancer 12. 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. 13. Expected life expectancy \< 1 year 14. 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. 15. Unwillingness or inability to comply with the procedures described in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in global myocardial perfusion reserve (MPR) index | 6months |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed