Investigating the clinical utility of a novel oral fluid heart failure point-of-care test.

研究一种新型口腔液心力衰竭即时检测的临床实用性。

• 批准号: 10045675
• 金额: $ 6.37万
• 依托单位: BIOHABIT LTD
• 依托单位国家: 英国
• 项目类别: Grant for R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10045675
• 关键词: Investigating; clinical; utility; novel; oral

Heart failure is common and carries a high mortality with around 40% of newly diagnosed patients dying each year in the UK. Although patients may complain of breathlessness, swollen legs and fatigue in the early stages, these symptoms are extremely non-specific, and 80% of cases are ultimately diagnosed in hospital.It is therefore critical that GPs and primary care teams are well equipped to make the diagnosis early and ensure timely medical intervention and specialist referral to a cardiologist. Whilst heart failure blood tests are already recommended by the National Institute for Health and Care Excellence for this purpose, up to one third of UK GPs still do not have access to the test. As a result, almost 200,000 patients each year in the UK are referred to secondary care based on signs and symptoms alone. Of these, two thirds will turn out not to have heart failure, costing the NHS more than £20 million of unnecessary annual expenditure.Meanwhile, although around a half of heart failure patients display symptoms that should trigger assessment in primary care, as many as 80% are diagnosed in the hospital emergency department in the context of a crisis. Once admitted, the additional associated financial burden amounts to more than £100 million due to long lengths of stay and poorer patient outcomes, much of which could be avoided.A new approach is clearly needed to save time and ensure efficient diagnosis for patients, but also to help GPs cut down consultation numbers and associated admin work and reduce the number of costly unnecessary referrals. A point-of-care test that could be performed in the surgery with an immediate result, that was inexpensive and non-invasive would allow GPs to rule in/out heart failure within the same consultation. Such a test would speed-up diagnosis massively, prevent unnecessary referrals and reduce hospitalisation rates with significant cost savings amounting to £110 per year.Biohabit Ltd is currently developing such non-invasive heart failure diagnostic test. The company has already demonstrated the proof-of-concept and is now starting clinical efficacy testing. Data and technical parameters generated in this project will allow the company to create a prototype of the proposed diagnostic device.Biohabit aims to sell the device to the NHS as well as health-conscious consumers, who will be able to purchase the test over-the-counter to assess the risk of developing heart failure and getting the upper hand in managing the cardiac health.

心力衰竭很常见，死亡率很高，在英国每年约有40%的新诊断患者死亡。虽然患者在早期可能会抱怨呼吸困难、腿部肿胀和疲劳，但这些症状非常非特异性，80%的病例最终在医院得到诊断。因此，全科医生和初级保健团队必须具备良好的装备，以便及早诊断，并确保及时进行医疗干预和心脏病专家转诊。虽然心力衰竭血液测试已经被国家健康和护理卓越研究所推荐用于此目的，但多达三分之一的英国全科医生仍然无法获得测试。因此，英国每年有近20万患者仅根据体征和症状就被转诊到二级护理。其中三分之二的人不会出现心力衰竭，NHS每年花费超过2000万英镑的不必要支出。同时，尽管约有一半的心力衰竭患者表现出应在初级保健中进行评估的症状，但多达80%的心力衰竭患者是在危机情况下在医院急诊科被诊断出来的。一旦入院，由于住院时间长和患者预后差，额外的相关经济负担超过1亿英镑，其中大部分是可以避免的。显然需要一种新的方法来节省时间并确保对患者的有效诊断，但也要帮助全科医生减少咨询次数和相关的管理工作，并减少昂贵的不必要的转诊次数。可以在手术中进行的即时检测，价格低廉，无创，可以让全科医生在同一次会诊中排除心力衰竭。这样的测试将大大加快诊断速度，防止不必要的转诊，并减少住院率，每年可节省110英镑的成本。Biohabit Ltd目前正在开发这种非侵入性心力衰竭诊断测试。该公司已经展示了概念验证，现在正在开始临床疗效测试。Biohabit的目标是将该设备出售给NHS以及具有健康意识的消费者，他们将能够购买非处方测试，以评估发生心力衰竭的风险，并在管理心脏健康方面占上风。