Back to resultsEffects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease
Primary Purpose
Coronary Artery Disease, Prediabetic State
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin 10mg
Lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Dapagliflozin, Lifestyle modification, Myocardial perfusion reserve
Eligibility Criteria
Inclusion Criteria:
- Men or women at least 18 years of age
- Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
- Stable coronary artery disease
- Global myocardial perfusion reserve (MPR) index < 2.0
- 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:
- Contraindications to dapagliflozin
- Significant renal disease manifested by eGFR<30 ml/min/1.73m²
- Unstable or rapidly progressing renal disease
- Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
- Stent placement, or coronary artery bypass graft surgery within the previous 6 months
- Planned revascularization within 6 months
- Significant disease (diameter stenosis >70% by coronary CT angiography) in major epicardial coronary arteries
- Heart failure requiring loop diuretics
- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- Contraindication to adenosine stress test
- Current treatment for the active cancer
- 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.
- Expected life expectancy < 1 year
- 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.
- Unwillingness or inability to comply with the procedures described in this protocol.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Dapagliflozin
Lifestyle modification
Arm Description
Outcomes
Primary Outcome Measures
Percent change in global myocardial perfusion reserve (MPR) index
Secondary Outcome Measures
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(systolic, diastolic both )
Full Information
NCT ID
NCT04330079
First Posted
March 30, 2020
Last Updated
September 21, 2022
Sponsor
CHEOL WHAN LEE, M.D., Ph.D
1. Study Identification
Unique Protocol Identification Number
NCT04330079
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment. (Difficulty in selecting subjects)
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
April 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEOL WHAN LEE, M.D., Ph.D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Prediabetic State
Keywords
Dapagliflozin, Lifestyle modification, Myocardial perfusion reserve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Title
Lifestyle modification
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10mg
Intervention Description
Dapagliflozin 10mg once daily for 6 months.
Intervention Type
Other
Intervention Name(s)
Lifestyle modification
Intervention Description
lifestyle modification (diet and exercise) for 6 months
Primary Outcome Measure Information:
Title
Percent change in global myocardial perfusion reserve (MPR) index
Time Frame
6months
Secondary Outcome Measure Information:
Title
Percent change in regional myocardial perfusion reserve (MPR) index
Time Frame
6months
Title
absolute changes in global MPR index
Time Frame
6months
Title
absolute changes in regional MPR index
Time Frame
6months
Title
Change in body weight
Time Frame
6months
Title
Change in blood pressure(systolic, diastolic both )
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women at least 18 years of age
Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
Stable coronary artery disease
Global myocardial perfusion reserve (MPR) index < 2.0
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:
Contraindications to dapagliflozin
Significant renal disease manifested by eGFR<30 ml/min/1.73m²
Unstable or rapidly progressing renal disease
Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
Stent placement, or coronary artery bypass graft surgery within the previous 6 months
Planned revascularization within 6 months
Significant disease (diameter stenosis >70% by coronary CT angiography) in major epicardial coronary arteries
Heart failure requiring loop diuretics
Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
Contraindication to adenosine stress test
Current treatment for the active cancer
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.
Expected life expectancy < 1 year
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.
Unwillingness or inability to comply with the procedures described in this protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol Whan Lee, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease
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