Effects of dapaglifloziN Therapy on myocardial perfusion Reserve in prediabetic patients with stable coronarY artery disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004802

Enrollment

Registered

2020-03-06

Start date

2020-05-21

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Others : * dapagliflozin group: dapagliflozin 10mg once daily for 6 months. * control group: lifestyle modification (diet and exercise) for 6 months

Eligibility

Sex/Gender

All

Inclusion 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) 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

Exclusion criteria: 1) Contraindications to dapapagliflozin 2) Significant renal disease manifested by creatinine clearance of(eGFR70% 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.

Design outcomes

Primary

Measure	Time frame
Percent change in global myocardial perfusion reserve (MPR) index	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJIWON BAEK

Asan Medical Center

cvcrc22@amc.seoul.kr+82-2-3010-7267

Outcome results