EUCTR2017-000124-95-GB进行中（未招募）1 期
Randomised Controlled Crossover Trial of Inhaled Furosemide for Dyspnoea Relief in Advanced Heart Failure - INFOD-HF V1.0
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
- 30
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
- •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 the investigator will ensure they have the capacity to understand, consent and have the ability to perform the studies required.)
- •3)Diagnosed with heart failure more than 3 months ago.
- •4)Diagnosed with heart failure with a documented reduced ejection fraction <40%
- •5)Significant breathlessness that limits what they are able to do. MRC Dyspnoea Scale =2.
- •6)In the Investigator's opinion, is able and willing to comply with all trial requirements.
- •7)Female participants of child bearing potential must be willing to ensure that they use effective contraception during the period they are taking the IMP/placebo and for 48hours after Visit 5.
- •8) Prescribed regular furosemide or bumetanide tablets for at least 1 month
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
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)Unplanned heart failure related hospital admission within the last month (unstable heart failure).
- •4)Patients diagnosed with heart failure within the last 3 months (unstable heart failure)
- •5)Individuals who are dehydrated or have significant symptomatic postural hypotension
- •6)Significant renal impairment (eGFR <15) or anuric
- •7)Potassium <3.0 or >5.9 or Sodium <130 or >150 over the preceding month prior the screening visit.
- •8)Significant hepatic impairment/cirrhosis (Child-Pugh class C)
- •9)Addison's disease
- •10)Digitalis intoxication
- •11)Porphyria
- •12)Individuals who are immunocompromised
- •13)Patient with life expectancy <6 months
- •14)Co-existent history of significant chronic obstructive pulmonary disease or asthma or interstitial lung disease or nasal polyps
- •15)Patients on inhaled B2 agonist therapy
- •16)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.
- •17)Have participated in another research trial involving investigational product in the past 4 weeks.
- •18)Female patients who are pregnant, lactating or planning pregnancy over the course of trial.
研究者
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