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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04330079
• Other study ID #: ENTRY trial
• Status: Terminated
• Phase: Phase 4
• Start date: May 21, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: September 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Prediabetic State

Intervention

Drug:
• Dapagliflozin 10mg
Dapagliflozin 10mg once daily for 6 months.

Other:
• Lifestyle modification
lifestyle modification (diet and exercise) for 6 months

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, M.D., Ph.D

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in global myocardial perfusion reserve (MPR) index		6months
Secondary	Percent change in regional myocardial perfusion reserve (MPR) index		6months
Secondary	absolute changes in global MPR index		6months
Secondary	absolute changes in regional MPR index		6months
Secondary	Change in body weight		6months
Secondary	Change in blood pressure(systolic, diastolic both )		6months