NCT06030843招募中2 期
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MAKE30
研究概览
简要总结
Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years or more
- •Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart regardless of ejection fraction
- •AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL
- •Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated urine NGAL
排除标准
- •Denied to participate in the study
- •Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100 mmHg or required inotropic support within last 24 hours)
- •Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic balloon pump)
- •Acute coronary syndrome
- •Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic, dehydration)
- •Anuria or requiring dialysis or expected to required dialysis within 24 hr
- •Baseline eGFR ≤ 20 ml/min/1.73m2 with or without dialysis initiated
- •Heart or kidney transplanted
- •Previously received any SGLT2i in the last 3 months before admission
- •Allergic to any SGLT2i
- •Type 1 diabetes mellitus
- •History of ketoacidosis, including diabetic ketoacidosis
- •Pregnancy
- •Comorbid conditions with an expected survival of less than 1 months such as end-stage liver or heart disease, or uncurable malignancy
研究组 & 干预措施
Empagliflozin
Experimental
Empagliflozin 10 mg po OD
干预措施: Empagliflozin 10 MG (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
MAKE30
时间窗: 30 days
The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization
次要结局
- Mechanical ventilation(30 days)
- Recurrent heart failure(30 days)
- Ventricular tachycardia or ventricular fibrillation(30 days)
- Reduction of prespecified renal biomarkers(30 days)
- In-hospital mortality rate(During admission)
- 30-days mortality rate(30 days)
- Initiation of Renal Replacement therapy(30 days)
- Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR(30 days)
- Vasoactive drug(30 days)
- Resuscitation following a cardiac arrest(30 days)
研究者
Nattachai Srisawat ,M.D.
Professor
Chulalongkorn University
研究点 (1)
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