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

Sponsor
Hongchang Guo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04340908
Collaborator
(none)
500
Enrollment
1
Location
2
Arms
28.9
Anticipated Duration (Months)
17.3
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Dapagliflozin 10 MG
  • Drug: Placebos
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment

Dapagliflozin 10 mg tablet

Drug: Dapagliflozin 10 MG
10 mg tablet, oral, once daily, 1-year treatment, postoperation
Other Names:
  • Forxiga
  • Placebo Comparator: Control

    matching placebo tablet

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

    Outcome Measures

    Primary Outcome Measures

    1. Difference in mean EF% between the treatment and control study arms [2 year]

      Echocardiography is used to assess cardiac function.

    2. Difference in NTproBNP between the treatment and control study arms [2 year]

      NT-proBNP is used to assess cardiac function.

    Secondary Outcome Measures

    1. All-cause postoperative mortality [2 year]

      All-cause mortality identified during two years follow-up.

    2. Rehospitalization for cardiovascular causes [2 year]

      Rehospitalization due to cardiovascular diseases during two years follow-up.

    3. Serious postoperative infection [2 year]

      Including postoperative sternal dehiscence, external genital infections, etc.

    4. Acute postoperative kidney injury [2 year]

      Acute postoperative kidney injury requiring renal replacement therapy

    5. Hypoglycemia [2 year]

      Identified using ICD9 and ICD10 codes and reported as rates.

    6. Duration of Hospitalization [2 year]

      Days from date of surgery to hospital discharge.

    7. Diabetic ketoacidosis [2 year]

      Identified using ICD9 and ICD10 codes and reported as rates.

    8. Lactic acidosis [2 year]

      Identified using ICD9 and ICD10 codes and reported as rates.

    9. Post operative atrial fibrillation [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Beijing Anzhen Hospital, Capital Mediacal UniversityBeijingBeijingChina100000

    Sponsors and Collaborators

    • Hongchang Guo

    Investigators

    • Study Chair: Lai, M.D., Beijing Anzhen Hospital
    • Study Director: Guo, M.D., Beijing Anzhen Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hongchang Guo, Attending doctor, Beijing Anzhen Hospital
    ClinicalTrials.gov Identifier:
    NCT04340908
    Other Study ID Numbers:
    • AZ-SGLT2i
    First Posted:
    Apr 10, 2020
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hongchang Guo, Attending doctor, Beijing Anzhen Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021