POST-CABGDM: Empagliflozin in Perioperative CABG

NCT ID: NCT04523064

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2024-01-30

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SGLT2i (empagliflozin)

Empagliflozin 25 mg 1 time day for three months

Group Type: ACTIVE_COMPARATOR

Empagliflozin 25 MG

Intervention Type: DRUG

Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.

Standard of care

Standard care treatment of diabetes patients in our center

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Empagliflozin 25 MG

Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.

Intervention Type: DRUG

Other Intervention Names

Jardiance 25 mg

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos V Serrano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coração - Hospital das Clinicas FMUSP

Locations

University of Sao Paulo Medical School - The Heart Institute

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

4957/19/176

Identifier Type: -

Identifier Source: org_study_id