POST-CABGDM: Empagliflozin in Perioperative CABG

NCT04523064 | Completed Phase 4 FDA Drug

• 1 other identifier: 4957/19/176
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Diabetes; Coronary artery disease; SGLT2i; CABG; Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria

  3 months

Secondary Outcomes (6)

• Atrial fibrillation

  3 months

• Pulmonary infection

  3 months

• Infection of surgical site

  3 months

• ICU readmission

  3 months

• Need for IV insulin

  3 months

Study Arms (2)

SGLT2i (empagliflozin)

ACTIVE COMPARATOR

Empagliflozin 25 mg 1 time day for three months

Drug: Empagliflozin 25 MG

Standard of care

NO INTERVENTION

Standard care treatment of diabetes patients in our center

Interventions

Empagliflozin 25 MG DRUG

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

Also known as: Jardiance 25 mg

SGLT2i (empagliflozin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo Medical School - The Heart Institute

São Paulo, São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

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

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Carlos V Serrano, MD, PhD

  Instituto do Coração - Hospital das Clinicas FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: September 22, 2020
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

BR (1)