Clinical trial NCT04340908: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Cardiac Surgery
Keywords: Diabetes Mellitus
Outcome
SGLT2 inhibitors
Cardiac Surgery
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Difference in mean EF% between the treatment and control study arms
timeFrame: 2 year
measure: Difference in NTproBNP between the treatment and control study arms
timeFrame: 2 year
Secondary outcomes:
measure: All-cause postoperative mortality
timeFrame: 2 year
measure: Rehospitalization for cardiovascular causes
timeFrame: 2 year
measure: Serious postoperative infection
timeFrame: 2 year
measure: Acute postoperative kidney injury
timeFrame: 2 year
measure: Hypoglycemia
timeFrame: 2 year
measure: Duration of Hospitalization
timeFrame: 2 year
measure: Diabetic ketoacidosis
timeFrame: 2 year
measure: Lactic acidosis
timeFrame: 2 year
measure: Post operative atrial fibrillation
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Mediacal University
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Lai, M.D.
role: STUDY_CHAIR
affiliation: Beijing Anzhen Hospital
name: Guo, M.D.
role: STUDY_DIRECTOR
References: