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Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340908
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hongchang Guo, Beijing Anzhen Hospital

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Cardiac Surgery Drug: Dapagliflozin 10 MG Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Treatment
Dapagliflozin 10 mg tablet
Drug: Dapagliflozin 10 MG
10 mg tablet, oral, once daily, 1-year treatment, postoperation
Other Name: Forxiga

Placebo Comparator: Control
matching placebo tablet
Drug: Placebos
matching placebo tablet, oral, once daily, 1-year treatment, postoperation




Primary Outcome Measures :
  1. Difference in mean EF% between the treatment and control study arms [ Time Frame: 2 year ]
    Echocardiography is used to assess cardiac function.

  2. Difference in NTproBNP between the treatment and control study arms [ Time Frame: 2 year ]
    NT-proBNP is used to assess cardiac function.


Secondary Outcome Measures :
  1. All-cause postoperative mortality [ Time Frame: 2 year ]
    All-cause mortality identified during two years follow-up.

  2. Rehospitalization for cardiovascular causes [ Time Frame: 2 year ]
    Rehospitalization due to cardiovascular diseases during two years follow-up.

  3. Serious postoperative infection [ Time Frame: 2 year ]
    Including postoperative sternal dehiscence, external genital infections, etc.

  4. Acute postoperative kidney injury [ Time Frame: 2 year ]
    Acute postoperative kidney injury requiring renal replacement therapy

  5. Hypoglycemia [ Time Frame: 2 year ]
    Identified using ICD9 and ICD10 codes and reported as rates.

  6. Duration of Hospitalization [ Time Frame: 2 year ]
    Days from date of surgery to hospital discharge.

  7. Diabetic ketoacidosis [ Time Frame: 2 year ]
    Identified using ICD9 and ICD10 codes and reported as rates.

  8. Lactic acidosis [ Time Frame: 2 year ]
    Identified using ICD9 and ICD10 codes and reported as rates.

  9. Post operative atrial fibrillation [ Time Frame: 7 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old at index date.
  2. Diagnosis of Type 2 Diabetes.
  3. Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
  4. eGFR ≥ 60 ml/min/1.73 m2.
  5. Patients who agree to receive treatment with SGLT2 inhibitors.
  6. Patients must be on current stable hemodynamic profile , without dehydration.

Exclusion Criteria:

  1. Diagnosis of Type 1 Diabetes.
  2. eGFR < 60 ml/min/1.73 m2.
  3. Unstable or rapidly progressive renal disease.
  4. Hypersensitivity to dapagliflozin or any excipients.
  5. Severe hepatic disease.
  6. Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
  7. Any other reason considered by a study physician to be inappropriate for inclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340908


Contacts
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Contact: Wei, M.D. +86 19800367660 weizhipeng@outlook.com

Locations
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China, Beijing
Beijing Anzhen Hospital, Capital Mediacal University Recruiting
Beijing, Beijing, China, 100000
Contact: Wei, M.D.       weizhipeng@outlook.com   
Sponsors and Collaborators
Hongchang Guo
Investigators
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Study Chair: Lai, M.D. Beijing Anzhen Hospital
Study Director: Guo, M.D. Beijing Anzhen Hospital
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Responsible Party: Hongchang Guo, Attending doctor, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT04340908    
Other Study ID Numbers: AZ-SGLT2i
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongchang Guo, Beijing Anzhen Hospital:
Diabetes Mellitus
Outcome
SGLT2 inhibitors
Cardiac Surgery
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs