2023-503602-37-00招募中3 期
Effect at 3 months of early empagliflozin initiation in cardiogenic shock patients on mortality, rehospitalization, left ventricular ejection fraction and renal function. A randomized multicentric open trial. (EMPASHOCK)
CHRU De Nancy7 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 7
- 主要终点
- Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): - Rank 1: time to all-cause death or heart transplant or mechanical ventricular assist. - Rank 2: time to rehospitalization for heart failure - Rank 3: left ventricular ejection fraction assessed by echocardiography
研究概览
简要总结
To compare the effect of early introduction of empagliflozin in addition to usual management versus usual management alone at 12 weeks on a hierarchical composite morbidity endpoint including all-cause death or transplantation or long-term mechanical assistance or rehospitalization for heart failure and left ventricular ejection fraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Intervention period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult patients ≥18 years old hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
- •Who must have been or is under catecholamine for at least 12 hours for the treatment of cardiogenic shock. The definition of cardiogenic shock is as follows, adapted from the SHARC expert consensus: it refers to a patient with cardiac dysfunction resulting in a systolic blood pressure lower than 90 mmHg for at least 30 minutes (or requiring the use of vasopressors, inotropes, or mechanical circulatory support to maintain a systolic blood pressure of at least 90 mmHg) with evidence of hypoperfusion (≥ 1): •Elevated arterial lactate (>2 mmol/L), • Acute renal failure (creatinine ≥ 2x the upper normal limit) or oliguria (e.g., urine output <0.5 mL/kg/h), • Acute liver failure (e.g., AST and/or ALT > 3x the upper normal limit), • Cold extremities or mottling or capillary refill time (CRT) ≥ 3 seconds, •Altered consciousness unexplained by another cause.
- •Person affiliated to a social security scheme
排除标准
- •GFR< 20 ml/min/1.73m
- •Specific cardiogenic shock context: a. cardiac transplant patient or on transplant list. b. of peripartum, adrenergic, non ischemic valvular, post embolic heart disease. c. related to cardiotropic drug intoxication. d. secondary to a cardiocirculatory arrest for which the patient remains comatose before inclusion..
- •Women of childbearing age without effective contraception
- •Type 1 diabete patient
- •Person referred to in Articles 10, 31, 32, 33 and 34 of EU Regulation 536/2014 (Pregnant woman, parturient or breastfeeding mother, Minor (not emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice))
- •Chronic dialysis
- •Patient on SGLT2 inhibitors prior to admission to intensive care unit or CCU
- •Known allergy to SGLT2 inhibitors or to any of its excipients (in particular, patients with hereditary disorders of galactose intolerance, total lactase deficiency or glucose or galactose malabsorption syndrome)
- •Patients on lithium.
- •Patient in shock for another cause or moribund (SAPS2> 90).
结局指标
主要结局
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): - Rank 1: time to all-cause death or heart transplant or mechanical ventricular assist. - Rank 2: time to rehospitalization for heart failure - Rank 3: left ventricular ejection fraction assessed by echocardiography
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): - Rank 1: time to all-cause death or heart transplant or mechanical ventricular assist. - Rank 2: time to rehospitalization for heart failure - Rank 3: left ventricular ejection fraction assessed by echocardiography
次要结局
- Death at 12 weeks
- Heart transplantation or long-term ventricular assistance at 12 weeks
- Rehospitalization for heart failure from hospital discharge to 12-week
- Left ventricular ejection fraction at 12 weeks
- Left ventricular relaxation and filling pressures assessed at 12 weeks: e' wave, E/e' ratio,
- Right ventricular function assessed at 12 weeks: TAPSE, S wave
- Number of patients requiring extra-renal purification between randomization and 12 weeks, and evolution of renal function assessed at randomization and at 12 weeks: glomerular filtration rate calculated by the CKD-EPI method
- Liver function assessed at randomization and at 12 weeks: Bilirubin, Prothrombin Ratio , SGOT, SGPT.
- Weight and NT-proBNP (at randomization and at 12 weeks).
研究者
Antoine KIMMOUN
Scientific
CHRU De Nancy
研究点 (7)
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