EUCTR2018-003692-35-DE进行中（未招募）1 期
Effects of empagliflozin on diuresis and renal function in patients with acute decompensated heart failure - EMPAG-HF
Friedrich Schiller University Jena0 个研究点目标入组 60 人开始时间: 2019年2月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients (between 18 - 85 years) with acute decompensated heart failure (HF).
- •Brain Natriuretic Peptide (BNP) >100 pg/ml, or N-terminal pro-BNP (NT-proBNP)>300 pg/ml as defined by current clinical guidelines for the diagnosis of acute decompensated HF (European Society of Cardiology 2016 HF guideline)
- •Patients with diabetes mellitus type 2 or impaired glucose tolerance as defined by current clinical guidelines (German and International Diabetes Society 2016: HbA1c>6.5 % (upper limit for this clinical Trial 12%) or fasting glucose >7.0 mmol/l or any incidental glucose level >11.1 mmol/l or abnormal oral glucose tolerance test with 2h plasma glucose >7.8 mmol/l) or on antidiabetic medication or antidiabetic diet or patients with normal glucose tolerance
- •Patients without cognitive impairment, i.e. they must be capable of understanding the nature, significance and implications of the clinical trial and to form a rational intention in the light of the Facts
- •Written informed consent obtained
- •For women with childbearing potential (until 2 years after menopause):
- •o Negative pregnancy test
- •o regular and correct use of a highly effective contraceptive method with an error rate of <1% per year (e.g. combined (estrogen and progesteron) hormonal contraception, (oral, intravaginal, transdermal), progesteron-only hormonal contraception, (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system ( IUS)) tubal ligation (female sterilization), hormon donating intrauterine device (hormonal spiral), double barrier methods, sexual abstinence, vasectomy of the partner)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Type 1 diabetes mellitus
- •Chronic Kidney Disease (CKD) with eGFR< 30 ml/min (if obviously not related to acute kidney injury), or end-stage renal failure with the need for chronic dialysis treatment
- •Acute kidney injury (AKI) =AKIN stage 2 or requiring dialysis treatment
- •Current medication with SGLT-2 inhibitors
- •Known intolerance or hypersensitivity to the active substance empagliflozin, lactose or any other of the excipients listed in section 6.1. of the SmPC
- •A contraindication or intolerance to furosemide
- •Acute heart failure without signs of congestion (dry” patient)
- •Indication for urgent coronary angiography or planned administration of a iodine based contrast agent within the next 6 days.
- •Need for hemofiltration or any other form of extracorporeal therapy
- •Planned surgery
- •Recent participation in another clinical trial (within the last 3 months before inclusion, so that medical product/s from previous trial participation/s have been fully washed out )
- •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
- •Ongoing reported alcohol abuse (daily alcohol intake of more than 2 drinks (liquor, beer or wine) in men and 1 drink in women, corresponding to 12/24 g of pure alcohol per day women / men and/ or obvious alcoholisation of the patient during screening )
研究者
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