Clinical trial NCT04330079: Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease
Official title: Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease (ENTRY Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Prediabetic State
Keywords: Dapagliflozin
Lifestyle modification
Myocardial perfusion reserve
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent change in global myocardial perfusion reserve (MPR) index
timeFrame: 6months
Secondary outcomes:
measure: Percent change in regional myocardial perfusion reserve (MPR) index
timeFrame: 6months
measure: absolute changes in global MPR index
timeFrame: 6months
measure: absolute changes in regional MPR index
timeFrame: 6months
measure: Change in body weight
timeFrame: 6months
measure: Change in blood pressure(systolic, diastolic both )
timeFrame: 6months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Cheol Whan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: