POST-CABGDM: Empagliflozin in Perioperative CABG

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Acute Kidney Injury; Diabetes Mellitus, Type 2; Coronary Artery Bypass Surgery

Treatments: Drug: Empagliflozin 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04523064

4957/19/176

Details and patient eligibility

About

Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. This work aims to evaluate the impact of a strategy to control Diabetes Mellitus using inhibitors of sodium-glucose cotransporters (ISGLT2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass

Full description

Random Prospective Study non-blinded with 144 diabetics patients designated to myocardial revascularization with cardiopulmonary bypass . 72 patients will be randomly set to usual treatment provided by health care service and 72 patients will be randomly assigned treatment based on ISGLT2 (Empaglifozin). Patients will receive treatment as set for 3 months until 3 days prior to surgery. Creatinine levels will be measured immediately after surgery and in the following 3 days in post-op.

To evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on ISGLT2.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18
• Type 2 diabetes mellitus
• Multivessel CAD documented by coronary angiography with formal indication for CRM.

Exclusion criteria

• eGFR <30mL / min / 1.73m2 or dialysis therapy;
• Inability to sign the informed consent form;
• Contraindication to CABG on pump;
• Need for urgent or emergency CABG;
• Terminal or disabling illness with reduced life expectancy;
• Pregnancy in progress.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

SGLT2i (empagliflozin)

Active Comparator group

Description:

Empagliflozin 25 mg 1 time day for three months

Treatment:

Drug: Empagliflozin 25 MG

Standard of care

No Intervention group

Description:

Standard care treatment of diabetes patients in our center