Back to resultsEffects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Primary Purpose
Diabetes Mellitus, Type 2, Cardiac Surgery
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dapagliflozin 10 MG
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Outcome, SGLT2 inhibitors, Cardiac Surgery
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old at index date.
- Diagnosis of Type 2 Diabetes.
- Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
- eGFR ≥ 60 ml/min/1.73 m2.
- Patients who agree to receive treatment with SGLT2 inhibitors.
- Patients must be on current stable hemodynamic profile , without dehydration.
Exclusion Criteria:
- Diagnosis of Type 1 Diabetes.
- eGFR < 60 ml/min/1.73 m2.
- Unstable or rapidly progressive renal disease.
- Hypersensitivity to dapagliflozin or any excipients.
- Severe hepatic disease.
- Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
- Any other reason considered by a study physician to be inappropriate for inclusion.
Sites / Locations
- Beijing Anzhen Hospital, Capital Mediacal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
Dapagliflozin 10 mg tablet
matching placebo tablet
Outcomes
Primary Outcome Measures
Difference in mean EF% between the treatment and control study arms
Echocardiography is used to assess cardiac function.
Difference in NTproBNP between the treatment and control study arms
NT-proBNP is used to assess cardiac function.
Secondary Outcome Measures
All-cause postoperative mortality
All-cause mortality identified during two years follow-up.
Rehospitalization for cardiovascular causes
Rehospitalization due to cardiovascular diseases during two years follow-up.
Serious postoperative infection
Including postoperative sternal dehiscence, external genital infections, etc.
Acute postoperative kidney injury
Acute postoperative kidney injury requiring renal replacement therapy
Hypoglycemia
Identified using ICD9 and ICD10 codes and reported as rates.
Duration of Hospitalization
Days from date of surgery to hospital discharge.
Diabetic ketoacidosis
Identified using ICD9 and ICD10 codes and reported as rates.
Lactic acidosis
Identified using ICD9 and ICD10 codes and reported as rates.
Post operative atrial fibrillation
In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 7 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or an f wave was detected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04340908
Brief Title
Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Official Title
Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hongchang Guo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with diabetes have poorer cardiac surgery outcomes compared with non-diabetics. Proper blood glucose management is critical to reduce the morbidity and mortality for diabetic patients after cardiac surgery.
SGLT2 inhibitors including dapagliflozin as a new diabetes drug can reduce heart failure hospitalization rates and overall cardiovascular mortality in patients with cardiovascular disease.
This study is to assess the impact of one year of treatment of SGLT2 inhibitors on cardiac function, postoperative complications and long-term cardiovascular mortality in diabetic patients undergoing cardiac surgery.
The investigators use echocardiography to evaluated cardiac function in diabetic patients during perioperative cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiac Surgery
Keywords
Diabetes Mellitus, Outcome, SGLT2 inhibitors, Cardiac Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg tablet
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
matching placebo tablet
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 MG
Other Intervention Name(s)
Forxiga
Intervention Description
10 mg tablet, oral, once daily, 1-year treatment, postoperation
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
matching placebo tablet, oral, once daily, 1-year treatment, postoperation
Primary Outcome Measure Information:
Title
Difference in mean EF% between the treatment and control study arms
Description
Echocardiography is used to assess cardiac function.
Time Frame
2 year
Title
Difference in NTproBNP between the treatment and control study arms
Description
NT-proBNP is used to assess cardiac function.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
All-cause postoperative mortality
Description
All-cause mortality identified during two years follow-up.
Time Frame
2 year
Title
Rehospitalization for cardiovascular causes
Description
Rehospitalization due to cardiovascular diseases during two years follow-up.
Time Frame
2 year
Title
Serious postoperative infection
Description
Including postoperative sternal dehiscence, external genital infections, etc.
Time Frame
2 year
Title
Acute postoperative kidney injury
Description
Acute postoperative kidney injury requiring renal replacement therapy
Time Frame
2 year
Title
Hypoglycemia
Description
Identified using ICD9 and ICD10 codes and reported as rates.
Time Frame
2 year
Title
Duration of Hospitalization
Description
Days from date of surgery to hospital discharge.
Time Frame
2 year
Title
Diabetic ketoacidosis
Description
Identified using ICD9 and ICD10 codes and reported as rates.
Time Frame
2 year
Title
Lactic acidosis
Description
Identified using ICD9 and ICD10 codes and reported as rates.
Time Frame
2 year
Title
Post operative atrial fibrillation
Description
In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 7 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or an f wave was detected.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old at index date.
Diagnosis of Type 2 Diabetes.
Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
eGFR ≥ 60 ml/min/1.73 m2.
Patients who agree to receive treatment with SGLT2 inhibitors.
Patients must be on current stable hemodynamic profile , without dehydration.
Exclusion Criteria:
Diagnosis of Type 1 Diabetes.
eGFR < 60 ml/min/1.73 m2.
Unstable or rapidly progressive renal disease.
Hypersensitivity to dapagliflozin or any excipients.
Severe hepatic disease.
Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
Any other reason considered by a study physician to be inappropriate for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei, M.D.
Phone
+86 19800367660
Email
weizhipeng@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lai, M.D.
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guo, M.D.
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Mediacal University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei, M.D.
Email
weizhipeng@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
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