Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure: a Multicentre, Phase II, Randomised, Parallel Group, Active Comparator Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 22
- 主要终点
- Days Alive Out of Hospital
研究概览
简要总结
To investigate whether an early supported discharge strategy for patients admitted to hospital because of HF, using a pH neutral subcutaneous (SC) furosemide formulation (SQINFurosemide) at home (delivered by non-CE marked SQINInfusor), compared to a usual care strategy with intravenous (IV) furosemide in hospital, results in an increased number of days spent alive and out of hospital (DAOH) at 30 days.
详细描述
HF is associated with frequent and lengthy hospitalisations. These hospitalisations are usually as a result of congestion, and the standard treatment of this is decongestion with intravenous (IV) diuretic (usually furosemide). This is usually delivered in a hospital setting. A new formulation of a pHneutral furosemide (SQIN-Furosemide) that can be delivered subcutaneously (SC) by a small patch pump (SQIN-Infusor) has been developed. Bioavailability of SQIN-Furosemide is similar to IV furosemide. This trial will test the efficacy and safety of novel SC furosemide 30mg/ml (SQIN-Furosemide), delivered in a home environment (compared to usual care strategy with IV furosemide delivered in secondary care) as part of a novel early supported discharge strategy in patients admitted to hospital with HF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Not possible
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female ≥18 years of age
- •Meet European Society of Cardiology (ESC) criteria for diagnosis of HF1
- •Elevated natriuretic peptide (BNP> 100 pg/mL or NTproBNP >300 pg/mL)
- •Signs and symptoms of HF
- •Echocardiographic structural or functional abnormality according to ESC guidelines
- •Have received IV diuretic for treatment of HF within preceding 24 hours
- •Be less than 96 hours after admission to hospital
- •Requiring IV diuretics for a minimum of 24 hours after screening
- •Have an echocardiogram or other assessment of cardiac structure and function within preceding 12 months or at screening
- •Have a home environment that allows the patient to be able to mobilise within their residence and be able to pass urine into their toilet (unless catheterised)
- •Able to operate (or has a caregiver who can operate) SQIN-Infusor (as assessed by training on a dummy device at screening)
排除标准
- •Unable to consent due to significant cognitive impairment or lack of capacity
- •Unable to operate SQIN-Infusor (or no caregiver who is able to operate the device)
- •Geographical reasons preventing follow-up visits
- •Pregnancy or breast-feeding
- •Requiring treatment with IV furosemide >250 mg furosemide per day in the opinion of the treating physician
- •Left sided valve disease with planned surgery or percutaneous intervention
- •Type 1 myocardial infarction during index hospitalisation (participants with type 2 myocardial infarction can be included)2
- •Renal impairment, defined as estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m 2 at screening
- •Reasons (other than HF) which may prevent discharge from hospital, such as social circumstances or other significant medical condition (at investigator discretion)
- •Women of childbearing potential
- •Patient on active cardiac transplant waiting list
- •Patient requiring on-going inotropic, vasopressor or intraaortic balloon pump support
- •Potassium <3.0 mmol/L
- •Potassium >6.0 mmol/L
- •Sodium <125 mmol/L
- •Any surgical or medical condition which, in the opinion of the investigator, may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data
研究组 & 干预措施
Early supported discharge
Open label, 1:1 randomisation to usual care in hospital vs early supported discharge with SQIN-Furosemide administered via SQIN-Infusor.
Early supported discharge: with SQIN-Furosemide and SQIN-Infusor. SQIN-Furosemide: 80mg of SQIN-Furosemide in each cartridge; 5 hours running time; up to 2 applications in 24h (maximum dose of 160mg of SQIN-Furosemide in 24h). SQIN-Infusor: patient/carer administered.
干预措施: SQIN-Furosemide (Drug)
Early supported discharge
Open label, 1:1 randomisation to usual care in hospital vs early supported discharge with SQIN-Furosemide administered via SQIN-Infusor.
Early supported discharge: with SQIN-Furosemide and SQIN-Infusor. SQIN-Furosemide: 80mg of SQIN-Furosemide in each cartridge; 5 hours running time; up to 2 applications in 24h (maximum dose of 160mg of SQIN-Furosemide in 24h). SQIN-Infusor: patient/carer administered.
干预措施: SQIN-Infusor (Device)
结局指标
主要结局
Days Alive Out of Hospital
时间窗: 30 days
Days spent alive and out of hospital (DAOH), from randomisation to 30 days.
次要结局
- Total number of HF hospitalisations at 60 days(60 days)
- Change in quality of life(60 days)
- Days Alive Out of Hospital(60 days)
- Length of index hospitalisation(30 days)
- CV death or first HF hospitalisation at 60 days(60 days)
- CV mortality at 60 days(60 days)
- Safety as determined by treatment emergent adverse events (TEAEs) (including serious adverse events [SAEs]) and adverse drug events (ADEs) (including serious adverse drug events [SADEs])(60 days)
- Any device failures (e.g., adhesive failure and drug delivery failure)(60 days)