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

niveristy Medical Center Groningen0 个研究点目标入组 80 人开始时间: 2017年9月7日最近更新: 2017年11月6日

适应症

试验速览

暂无简介。

•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
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. Dyspnea primarily due to non-cardiac causes
•2. Cardiogenic shock
•3. Acute coronary syndrome within 30 days prior to randomization
•4. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
•3. Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L)
•4. Pregnant or nursing (lactating) women
•5. Current participation in any interventional study
•6. Inability to follow instructions or comply with follow-up procedures
•7. 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.

发起方

niveristy Medical Center Groningen