NCT04340908

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2021

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

April 2, 2020

Last Update Submit

October 6, 2021

Conditions

Diabetes Mellitus, Type 2Cardiac Surgery

Keywords

Diabetes MellitusOutcomeSGLT2 inhibitorsCardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • Difference in mean EF% between the treatment and control study arms

    Echocardiography is used to assess cardiac function.

    2 year

  • Difference in NTproBNP between the treatment and control study arms

    NT-proBNP is used to assess cardiac function.

    2 year

Secondary Outcomes (9)

  • All-cause postoperative mortality

    2 year

  • Rehospitalization for cardiovascular causes

    2 year

  • Serious postoperative infection

    2 year

  • Acute postoperative kidney injury

    2 year

  • Hypoglycemia

    2 year

  • +4 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Dapagliflozin 10 mg tablet

Drug: Dapagliflozin 10 MG

Control

PLACEBO COMPARATOR

matching placebo tablet

Drug: Placebos

Interventions

Dapagliflozin 10 MGDRUG

10 mg tablet, oral, once daily, 1-year treatment, postoperation

Also known as: Forxiga
Treatment
PlacebosDRUG

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Mediacal University

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lai, M.D.

    Beijing Anzhen Hospital

    STUDY CHAIR

  • Guo, M.D.

    Beijing Anzhen Hospital

    STUDY DIRECTOR

Central Study Contacts

Wei, M.D.

CONTACT

+86 19800367660weizhipeng@outlook.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 10, 2020

Study Start

January 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2023

Last Updated

October 7, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)