Effect of Early Empagliflozin Initiation in Cardiogenic Shock.

N/AActive Not RecruitingNCT07450417

Central Hospital, Nancy, France418 enrolled

Overview

Cardiogenic shock represents a severe condition of heart pump dysfunction. Despite advances in medical management, the mortality rate for this condition remains high. Conventional treatments for cardiovascular diseases have several side effects that make their use impossible in patients with cardiogenic shock. A new class of drugs has been developed in recent years and is an integral part of the management of patients with chronic heart failure. These are sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), namely empagliflozin and dapagliflozin. This therapeutic class has proven effective in reducing mortality as well as hospital readmissions for heart failure patients. Given their effectiveness in acute heart failure, which is physiologically closest to the cardiogenic shock population, and their good tolerance, SGLT2 inhibitors are increasingly being prescribed to patients with cardiogenic shock to improve long-term outcomes. In order to improve medical knowledge and the management of patients in cardiogenic shock, the main objective of this research is to compare, in these patients, the effect of the early introduction of treatment with sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), in addition to usual care, versus usual care alone, on all-cause mortality and rehospitalization for heart failure at 12 weeks.

Study Type

OBSERVATIONAL

Enrollment

418

Conditions

Cardiogenic Shock

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over 18 years old; * Hospitalized in an Intensive Care or Cardiac Intensive Care unit in cardiogenic shock; * Hospitalized at CHRU of NANCY between 01/01/2018 and 31/12/2023. Exclusion Criteria: At admission to intensive care/cardiac intensive care for cardiogenic shock: * eGFR \< 20 ml/min/1.73m² * Chronic dialysis patient * Patient on SGLT2 inhibitors prior to admission to intensive care or cardiac intensive care * Cardiogenic shock: * a) From peripartum cardiomyopathy, adrenergic, restrictive, or post-embolic * b) Due to drug-induced cardiotoxicity * c) Secondary to a cardiac arrest with more than 25 minutes of "low flow" or more than 5 minutes of "no flow" before recovery of stable cardiac activity * Adult subject under a legal protective measure (guardianship, curatorship, judicial safeguard)

Outcomes

Primary Outcomes

Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure)

To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on composite endpoint components: 1- All-cause mortality 2-rehospitalization for heart failure

Time frame: 12 weeks

Secondary Outcomes

Time to death

To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on all-cause mortality at 12 weeks

Time frame: 12 weeks

time to rehospitalization for heart failure

To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on time to rehospitalization for heart failure, at 12 weeks

Time frame: 12 weeks

KDIGO score

To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on Acute kidney injury onset defined by the maximal KDIGO score reached in intensive care unit.

Time frame: from admission to 90 days post admission

Renal replacement therapy

To compare the effect of early introduction of empagliflozin in addition to standard management versus standard management alone on renal replacement therapy

Time frame: 12 weeks

Effect of Early Empagliflozin Initiation in Cardiogenic Shock.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes