EUCTR2015-001468-21-GB进行中(未招募)1 期
Inhaled furosemide for dyspnoea relief in advanced heart failure - Inhaled furosemide for dyspnoea relief in advanced heart failure
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 12
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
入选标准
- •1)Patient is willing and able to give informed consent for participation in the trial.
- •2)Male or Female, aged 18 years or above. (There is no upper age limit although it will be at the discretion of the investigator to ensure they have the capacity to understand, consent and have the ability to perform the studies required).
- •3)Diagnosed with NYHA stage III or IV heart failure
- •4)Treated with oral furosemide for at least 3 weeks
- •5)Ambulatory and clinically stable in the previous 3 months
- •6)Documented left ventricular ejection fraction (LVEF) of <35%.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1)Those unable to consent for themselves
- •2)History of allergic reaction (hypersensitive) to furosemide and/or any of the other ingredients of furosemide or amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole
- •3)Individuals who are dehydrated or have significant symptomatic postural hypotension
- •4)Significant renal impairment (eGFR <15) or anuric
- •5)Significant hepatic impairment/cirrhosis (Child-Pugh class C)
- •6)Addison's disease
- •7)Digitalis intoxication
- •8)Porphyria
- •9)Individuals who are immunocompromised
- •10)Patient with life expectancy <6 months
- •11)Patients who are inappropriate for saline
- •12)Co-existent history of significant chronic obstructive pulmonary disease or asthma or interstitial lung disease or nasal polyps
- •13)Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial.
- •14)Have participated in another research trial involving investigational product in the past 4 weeks.
- •15)Patients who have had an admission to hospital with heart failure within the last 3 months
- •16)Female patients who are pregnant, lactating or planning pregnancy over the course of trial.
研究者
相似试验
已完成
不适用
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