Effects of dapaglifloziN Therapy on myocardial perfusion Reserve in prediabetic patients with stable coronarY artery disease
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0004802
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 60
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)
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.
1) Contraindications to dapapagliflozin
2) Significant renal disease manifested by creatinine clearance of(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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in global myocardial perfusion reserve (MPR) index
- Secondary Outcome Measures
Name Time Method Percent change in regional myocardial perfusion reserve (MPR) index;absolute changes in global MPR index;absolute changes in regional MPR index;Change in body weight;Change in blood pressure