Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure (LOVE-HF) Double Blinded Pilot Randomised Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Proportion of participants we can establish number of days alive out of hospital
研究概览
简要总结
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited for the LOVE-HF trial at Blackpool Victoria Hospital.
Eligible participants will be randomized to use the Heartfelt Device alongside standard care (weighing + symptom reporting), or standard care alone. Participants and clinicians will be blinded (double blind) as to which arm participants are in, and after 30 days, participants will be crossed over to the other arm. This can be done without disrupting patients as the Heartfelt device can be switched remotely from a 'technical checks only' mode to a 'full data analysis' mode and vice versa. The investigators aim to recruit 30 participants for the pilot study. The study will also run in parallel with its sister pilot trial, LOVE-HF-2.
Through this study, we are testing the capability to get the answers from patients, healthcare systems, and devices, in order to inform future clinical trial design.
详细描述
Heart Failure is the final common pathway of most forms of cardiovascular disease. In the United Kingdom (UK), it affects around 900 000 people, causes or complicates around 5% of adult emergency hospital admissions and consumes up to 2% of total National Health Service (NHS) expenditure. An important part of discharge planning includes measures such as early follow up in order to prevent readmissions. The hallmark of heart failure is fluid retention and between 2009 and 2016, 43% to 50% of hospital admissions were associated with peripheral oedema. Therefore, early recognition of this and treatment of the congestion may prevent hospital admissions. In clinical trials, management strategies have included patient education, telemedicine and remote monitoring. The main non-invasive method for detecting fluid retention has been the use of weight as a surrogate marker.
The Heartfelt device is an invention that uses a system of cameras in a compact device in order to generate 3 dimensional images of the feet and lower legs. The volumes can then be calculated and thus, changes in amount of peripheral oedema can be estimated. In a clinical trial (NCT02993601) performed by the Heart Failure team at the Royal Brompton Hospital, there was good correlation between measurements made by Heartfelt and a water displacement method. The resolution was as good as 20mls.
By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Images are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. Personal identifiable data (participant name, address, age...) is stored on an encrypted hard drive, along with linkage information (device serial numbers) to associate the participant identifiable data with the data captured in the home. Therefore, data collection is not only secure but entirely passive, which is a major advantage compared with previous non-invasive methods and it is applicable to a very wide range of compliant and non-compliant patients.
Our hypothesis is that the Heartfelt device can directly detect the increase in peripheral oedema associated with heart failure decompensation and that, on average, the number of days with missing data collected by the Heartfelt device will be lower than that of the weighing scales.
Blackpool Victoria Hospital provides acute heart failure service both for in-patients and out-patients, including capacity to administer parenteral furosemide in hospital cardiac day case unit, community or home settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants in both arms of the study will have the Heartfelt device installed. The Heartfelt device will be able to operate in two modes: "technical checks only" mode and "full data analysis" mode. Only participants in Arm A (Heartfelt device + weight + symptom reporting) will have the device in "full data analysis" mode. Participants in Arm B (weight + symptom reporting) will have the device in "technical checks only" mode where the data analysis pipeline will be blocked and therefore will not be detecting changes in foot volume.
Only members of staff at Heartfelt Technologies not otherwise involved in the study will pre-set the devices in the relevant mode. The mode of the device will not be known by anyone in contact with the participants or the participants themselves. The switch between the two modes can be done remotely, to maintain blinding. The team will also receive alerts at random in the "technical checks only" mode to maintain blinding.
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
- •Patients with HF who recently (<6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) treated with at least 80 mg furosemide (or equivalent)/day.
- •Patients with HF ≥18 years.
- •Note that the research team will try to include as many patients as possible in the month following discharge, however we will not exclude consideration of a small proportion of patients within 6 months of decompensation. This has the extra advantage of demonstrating value of the device beyond 1-2 months of decompensation.
排除标准
- •Inability to provide informed consent *
- •Participant has bandages to lower limbs everyday
- •Participant has an amputation of the foot
- •Participant is a regular wheelchair user
- •Participant is of no fixed abode
- •Participant has potentially reversible cause of decompensated heart failure and is awaiting urgent intervention (revascularisation/ valvular heart disease), which means the patient cannot be discharged for home-based care.
- •Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation by and/or impact clinical interventions and participant outcomes.
- •Participant must not be pregnant, and is taking relevant birth control if of child-bearing potential*
- •Note that a participant not able to comply with weighing is NOT an exclusion criteria as the Heartfelt Device should provide data for these participants despite their lack of ability to adhere to the usual monitoring protocol, and this is seen as one of the long term benefits that the device can provide.
- •Note that the exclusion criteria (a) has been added as participants would need to be able to give individual responses to questionnaires, communicate directly with the Heartfelt team, etc.
- •Note that the exclusion criteria (h) has been requested by the insurance for clinical trial cover.
结局指标
主要结局
Proportion of participants we can establish number of days alive out of hospital
时间窗: 60 days
The proportion of participants for whom we can collect data to establish the number of days alive and out of hospital.
次要结局
- Proportion of participants we can establish date of emergency hospital admission which is HF related(60 days)
- Proportion of participants we can establish date of emergency hospital admission due to any cause(60 days)
- Proportion of participants we can establish date of planned hospital admission which is HF related(60 days)
- Proportion of participants who complete study questionnaires(60 days)
- True alerts - oedema(60 days)
- Proportion of participants we can establish date of death(60 days)
- True alerts - diuretics(60 days)
- Proportion of participants we can establish date of planned hospital admission due to any cause(60 days)
- Proportion of participants we can establish number of days alive and well out of hospital(60 days)
- Proportion of participants we can establish their quality of life(60 days)
- Proportion of participants we can establish symptom reporting(60 days)
- Proportion of participants we can establish cause of death(60 days)