Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality and Rehospitalization. Retrospective Monocentric Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Patient in cardiogenic shock
Patients hospitalized in Intensive Care or Cardiac Intensive Care at the CHRU of Nancy between January 1, 2018, and December 31, 2023, for cardiogenic shock and treated or not early with SGLT2 inhibitors.
干预措施: Patient in cardiogenic shock treated or not early with SGLT2 inhibitors. (Drug)
结局指标
主要结局
Hierarchical composite endpoint (Rank 1: Time to all-cause death; Rank 2: Time to rehospitalization for heart failure)
时间窗: 12 weeks
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
次要结局
- Time to death(12 weeks)
- time to rehospitalization for heart failure(12 weeks)
- KDIGO score(from admission to 90 days post admission)
- Renal replacement therapy(12 weeks)
研究者
Dr Antoine KIMMOUN
Principal investigator
Central Hospital, Nancy, France