Back to resultsDapagliflozin Therapy In Cardiac Surgery
Primary Purpose
Diabetes Mellitus, Type 2, Cardiac Surgery
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dapagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring SGLT2 inhibitors, Cardiac Surgery, Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years at screening Scheduled for cardiac surgery Diagnosis of Type 2 Diabetes Provision of signed informed consent prior to any study specific procedures Exclusion Criteria: Emergency surgery and non-primary surgery Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics History of diabetic ketoacidosis; type 1 diabetes mellitus Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation Serious hepatic disease Women who are pregnant, nursing, or who plan to become pregnant while in the trial Currently enrolled in another investigational drug study, or less than 30 days
Sites / Locations
- National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dapagliflozin
Standard of care
Arm Description
Dapagliflozin 10 mg
Standard care treatment of diabetes patients during perioperative cardiac surgery in our center
Outcomes
Primary Outcome Measures
Hs-Troponin-I
high sensitive cardiac troponin-I
Secondary Outcome Measures
NT-proBNP
N-terminal prohormone of brain natriuretic peptide
Postoperative atrial fibrillation
In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave
cardiac function
Echocardiography is used to assess cardiac function
Renal function
Change of creatinine values, need for renal replacement therapy
Abnormal blood potassium concentration
blood potassium concentration<3.5mmol/L or >5.5mmol/L
postoperative blood glucose level
hs-C-reactive protein
Hs-Troponin-I
Full Information
NCT ID
NCT05621551
First Posted
November 4, 2022
Last Updated
November 10, 2022
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT05621551
Brief Title
Dapagliflozin Therapy In Cardiac Surgery
Official Title
Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
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
This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery
Detailed Description
Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing 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
SGLT2 inhibitors, Cardiac Surgery, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard care treatment of diabetes patients during perioperative cardiac surgery in our center
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
The patients is required to receive dapagliflozin(10mg, q.d.) at least for 3 days until 24 hours before the surgery. Then dapagliflozin will be discontinued and recovered as soon as the patient is able to take oral diet postoperatively. Dapagliflozin wil be ceased five days after surgery.
Primary Outcome Measure Information:
Title
Hs-Troponin-I
Description
high sensitive cardiac troponin-I
Time Frame
within 2 days after surgery
Secondary Outcome Measure Information:
Title
NT-proBNP
Description
N-terminal prohormone of brain natriuretic peptide
Time Frame
within 5 days after surgery
Title
Postoperative atrial fibrillation
Description
In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave
Time Frame
within 5 days after surgery
Title
cardiac function
Description
Echocardiography is used to assess cardiac function
Time Frame
within 5 days after surgery
Title
Renal function
Description
Change of creatinine values, need for renal replacement therapy
Time Frame
within 5 days after surgery
Title
Abnormal blood potassium concentration
Description
blood potassium concentration<3.5mmol/L or >5.5mmol/L
Time Frame
within 5 days after surgery
Title
postoperative blood glucose level
Time Frame
within 5 days after surgery
Title
hs-C-reactive protein
Time Frame
within 5 days after surgery
Title
Hs-Troponin-I
Time Frame
within 5 days after surgery
Other Pre-specified Outcome Measures:
Title
Safety Outcome
Description
Number of Adverse Events, Serious Adverse Events, Diabetic ketoacidosis, Severe hypoglycemic events, hypovolemia, urogenital tract infection
Time Frame
In-hospital time, an average of 2 weeks
Title
Major adverse cardiac cerebrovascular events
Description
Exploratory endpoints
Time Frame
30 days
Title
all-cause mortality
Description
Exploratory endpoints
Time Frame
30 days
Title
Incision infection
Description
Exploratory endpoints
Time Frame
In-hospital time, an average of 2 weeks
Title
ICU readmission
Description
Exploratory endpoints
Time Frame
In-hospital time, an average of 2 weeks
Title
ICU stay
Description
Exploratory endpoints
Time Frame
Length of ICU stay after surgery，an average of 3 days
Title
Length of in-hospital time
Description
Exploratory endpoints
Time Frame
In-hospital time, an average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years at screening
Scheduled for cardiac surgery
Diagnosis of Type 2 Diabetes
Provision of signed informed consent prior to any study specific procedures
Exclusion Criteria:
Emergency surgery and non-primary surgery
Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics
History of diabetic ketoacidosis; type 1 diabetes mellitus
Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation
Serious hepatic disease
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Currently enrolled in another investigational drug study, or less than 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Zheng, MD,PhD
Phone
+86-010-88396051
Email
zhengzhe@fuwai.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongchen Li, MD
Email
lizhongchen@fuwai.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD,PhD
Organizational Affiliation
Fuwai Hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, Poprofessor
Phone
010-88396051
12. IPD Sharing Statement
Learn more about this trial
Dapagliflozin Therapy In Cardiac Surgery
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