Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
- Conditions
- Heart Failure, DiastolicDecompensated HeartfailureEdema Brain
- Interventions
- Device: Heartfelt-1Device: Weighing scalesOther: Medical grading of oedemaOther: Baseline assessementsDevice: Water displacement methodDevice: Callipers measurementsDevice: Measuring tape
- Registration Number
- NCT02993601
- Lead Sponsor
- Heartfelt Technologies
- Brief Summary
The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering from heart failure, who have peripheral oedema. The device is non-contact and does not requires patient compliance to work. It gives an output reading of the patient's lower leg volume.
During the study, this measurement will be compared to clinical standard and gold standard measurements as well as clinical grading of peripheral oedema.
- Detailed Description
The Heartfelt-1 device is a CE (Conformité Européenne = European Conformity) mark medical device used to measure biometric parameters of the foot and lower leg. The study aims at assessing the usefulness in patients suffering from heart failure, who have peripheral oedema. Models used for the measurements of foot and lower legs have not yet been validated for this group of patients, who are likely to have feet with abnormal surface contours and appearance secondary to oedema. Peripheral oedema can be a leading indicator of heart failure de-compensation which can lead to hospitalisation of patients, and therefore the device could be a useful clinical tool to monitor patients in their home. The Heartfelt-1 device has the ability to recognise the patient's feet (amongst an average size household setting), and trigger automatically the measurements when the feet are naked (for example as the patient goes in and out of bed). This makes the device an obvious choice for patients with compliance issues with current methods of monitoring (e.g. daily use of weighing scales) and treatment (e.g. diuretics) if it could be validated in this patient group.
The study has two general aims:
The first is to collect a time-series of data on inpatients with peripheral oedema caused by heart failure, as they receive intravenous or oral diuretic treatment to remove excess fluid and achieve optimal body weight and fluid balance. This data will be used both to determine the attainable resolution of foot biometric measurements on a patient as their fluid status changes, and also to further develop the algorithms used in the device and make them usable on a wide range of feet/lower legs which have been deformed by oedema. The data required for this study are images taken using the Heartfelt-1 device, as well as validation measurements such as the figure of eight using a medical grade tape measure, callipers, or the water displacement method using a volumetric gauge, at multiple time-points whilst the peripheral oedema reduces.
The second, on a second group of stable ambulatory (Heart Failure) HF patients with variable levels of oedema, is to evaluate the performance of the Heartfelt-1 device in determining foot biometric parameters one a wide range of patients at a single point in time. Patients with stable chronic heart failure will have their foot/lower legs measured by the Heartfelt-1 device, as well as standard medical measurement (figure of eight using a medical grade tape measure, callipers) and gold standard measurement (water displacement method using a gauge), as well as the patient's weight and a clinical grading of oedema. These will be compared and an estimate of the accuracy of the Heartfelt-1 device over this wider patient group can be extrapolated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Inpatients with admission for de-compensated heart failure requiring increase or initiation of diuretic therapy for fluid congestion.
- Patients attending cardiology outpatients at the Royal Brompton hospital with a diagnosis of heart failure and fluid retention.
- Cardiology patient without fluid retention (cardiology controls) Non-Cardiology patient without fluid retention (controls)
- Patients unable to provide informed consent.
- Unstable arrhythmias in previous 48 hours
- Systolic BP<90mmHg or need for inotropic support
- Ulceration on lower limbs (below shin) - excluded from water displacement but could have image recording and calipers
- Inability to transfer from bed to chair
- Patients with broken skin or cellulitis will not have their foot volume measured using the water displacement equipment to reduce the risk of infection for the patient and other participants.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 20 outpatients with peripheral oedema Weighing scales 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. 20 outpatients with peripheral oedema Baseline assessements 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. 20 outpatients with peripheral oedema Medical grading of oedema 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. 20 cardiology controls Baseline assessements 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. 10 in-patients peripheral oedema Heartfelt-1 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema. 10 in-patients peripheral oedema Callipers measurements 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema. 20 outpatients with peripheral oedema Heartfelt-1 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. 20 outpatients with peripheral oedema Measuring tape 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. 20 cardiology controls Weighing scales 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. 20 cardiology controls Measuring tape 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. 20 outpatients with peripheral oedema Water displacement method 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. 20 outpatients with peripheral oedema Callipers measurements 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. 20 cardiology controls Medical grading of oedema 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. 10 in-patients peripheral oedema Medical grading of oedema 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema. 20 cardiology controls Heartfelt-1 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. 20 cardiology controls Water displacement method 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. 20 cardiology controls Callipers measurements 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. 10 in-patients peripheral oedema Measuring tape 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema. 30 control without cardiac conditions Heartfelt-1 less than 30 normal controls (healthy volunteers and patients without heart failure) in the age group 55 and above who agree to have images taken using the Heartfelt-1 device (not the whole set of measurements). 10 in-patients peripheral oedema Weighing scales 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema. 10 in-patients peripheral oedema Baseline assessements 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema. 10 in-patients peripheral oedema Water displacement method 10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema.
- Primary Outcome Measures
Name Time Method Volume as measured by the Heartfelt-1 device Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
- Secondary Outcome Measures
Name Time Method Weight Within 3 months after patient recruitment or before the end of the study (whichever is soonest). Patient weight on the day
Circumference and "figure of eight" Within 3 months after patient recruitment or before the end of the study (whichever is soonest). Lower leg / foot circumference and "figure of eight" measurement
Medical grading of oedema Within 3 months after patient recruitment or before the end of the study (whichever is soonest). Medical grading of peripheral oedema on a scale 1-5
Distance measurements Within 3 months after patient recruitment or before the end of the study (whichever is soonest). Distance measurements on the foot / lower leg of the patient
Volume of the lower leg/foot Within 3 months after patient recruitment or before the end of the study (whichever is soonest). As measured using the water displacement method.
Trial Locations
- Locations (1)
Royal Brompton Hospital
🇬🇧London, United Kingdom