NL-OMON46516已完成2 期
Randomized, double blind, placebo controlled, multicenter pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure - EMPA-RESPONSE-AHF
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female >18 years of age;
- •2. Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
- •a. Dyspnea at rest or with minimal exertion
- •b. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph
- •c. BNP *350 pg/mL or NT-proBNP *1,400 pg/mL (for patients with AF: BNP*500 pg/mL or NT-proBNP *2,000 pg/mL)
- •d. Treated with loop diuretics at screening
- •3. Able to be randomized within 24 hours from presentation to the hospital
- •4. Able and willing to provide freely given written informed consent
- •5. eGFR (CKD-EPI) *30 ml/min/1.73m2 between presentation and randomization
排除标准
- •1. Diabetes Mellitus Type I
- •2. Dyspnea primarily due to non-cardiac causes
- •3. Cardiogenic shock
- •4. Acute coronary syndrome within 30 days prior to randomization
- •5. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to
- •randomization
- •6. Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L)
- •7. Pregnant or nursing (lactating) women
- •8. Current participation in any interventional study
- •9. Inability to follow instructions or comply with follow-up procedures
- •10. Any other medical conditions that may put the patient at risk or influence study results in the investigator*s opinion, or that the investigator deems unsuitable for the study.
研究者
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