Status:
TERMINATED
Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease
Lead Sponsor:
CHEOL WHAN LEE, M.D., Ph.D
Conditions:
Coronary Artery Disease
Prediabetic State
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. Dapagli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04330079
Start Date
May 21 2020
End Date
April 8 2021
Last Update
September 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea