2024-517977-26-00招募中3 期
Effects of continued administration of empagliflozin in patients with heart failure on active SGLT2 inhibitor treatment admitted for acute decompensated heart failure
Friedrich-Schiller-Universitaet Jena5 个研究点 分布在 1 个国家目标入组 556 人开始时间: 2025年8月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 556
- 试验地点
- 5
- 主要终点
- The study uses a four-step hierarchical composite primary endpoint: 1) time to all-cause death (day 90) 2) number of heart failure events per patient (day 90) 3) time to first heart failure event (day 90) 4) eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)
研究概览
简要总结
To assess the non-inferiority of continued administration of empagliflozin 10 mg versus placebo plus standard medical care in patients admitted with acute decompensated heart failure (ADHF) with prior treatment using a SGLT2 inhibitor on the combined endpoint of all-cause mortality, HF hospitalization and worsening renal function at 90 days after admission.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- After Hospital Discharge
- 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
- 否
入选标准
- •Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor
- •Brain Natriuretic Peptide (BNP) >100 pg/ml or N-terminal pro-BNP (NT-proBNP) >300 pg/ml
- •Written informed consent obtained
- •Negative pregnancy test for women of childbearing potential
排除标准
- •Type 1 diabetes mellitus
- •Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism)
- •Incapacity to understand and / or to provide written informed consent
- •Obvious uncontrolled substance abuse
- •Pregnancy, breastfeeding
- •Chronic Kidney Disease (CKD) with eGFR<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment
- •Acute kidney injury (AKI) requiring dialysis treatment
- •Known intolerance to empagliflozin
- •Acute heart failure without signs of congestion (“dry” patient)
- •Indication for coronary angiography or any foreseeable administration of a contrast media
- •Need for hemofiltration or any other form of extracorporeal therapy
- •Planned surgery
- •Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion)
结局指标
主要结局
The study uses a four-step hierarchical composite primary endpoint: 1) time to all-cause death (day 90) 2) number of heart failure events per patient (day 90) 3) time to first heart failure event (day 90) 4) eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)
The study uses a four-step hierarchical composite primary endpoint: 1) time to all-cause death (day 90) 2) number of heart failure events per patient (day 90) 3) time to first heart failure event (day 90) 4) eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)
次要结局
- Cardiovascular and total mortality on day 90
- Number of patients alive and without re-hospitalization on day 90
- Re-hospitalization after initial discharge, including reason (time to first re-hospitalization after discharge, numbers of re-hospitalizations)
- Number of patients with a decrease in eGFR of 5 ml/min/1.73 m² or more from baseline to day 90
- Daily and cumulative urine output (UOP) measured from day 1 to day 6
- Diuretic efficiency (ml urine per mg furosemide equivalent) from day 1 to day 6
- Change in body weight from baseline to day 1, day 3, day 6, discharge, day 30, and day 90
- Renal function at baseline, day 3, day 6, day 30, and day 90 : •Decrease in eGFR of >20 ml/min/1.73 m2 •Doubling of serum creatinine •Need for renal replacement therapy •Total urinary sodium excretion and fractional excretion of sodium
- Liver function (bilirubin, serum aminotransferases, relevant change in coagulation status) at baseline, day 3, day 6, day 30, and day 90
- Change in NT-proBNP (alternatively calculated from BNP) from baseline to day 6, day 30, and day 90
- Quality of life (EQ-5D-3L questionnaire) on day 0, at hospital discharge, and on day 30
- Severity of HF (KCCQ-12 questionnaire) on day 0, at hospital discharge, and on day 30
- IMC / ICU and hospital length of stay
- Single parameters of primary endpoint
研究者
Prof. Dr. Christian Schulze
Scientific
Friedrich-Schiller-Universitaet Jena
研究点 (5)
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