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

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

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease; Prediabetic State

Treatments: Drug: Dapagliflozin 10mg; Other: Lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04330079

ENTRY trial

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Dapagliflozin

Experimental group

Treatment:

Drug: Dapagliflozin 10mg

Lifestyle modification

Other group

Treatment:

Other: Lifestyle modification