Clinical trial NCT02993601: Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
Official title: Evaluation of the Safety and Feasibility of a New Peripheral Oedema Monitor for Home and Clinical Use for Heart Failure Patients, Using the Heartfelt-1 Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Diastolic
Edema Brain
Decompensated Heartfailure
Keywords: Heart Failure
Edema
Oedema
Decompensated Heartfailure
Lead sponsor: Heartfelt Technologies
Sponsor class: INDUSTRY
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2016-12-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults able to give consent to take part in the study

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Volume as measured by the Heartfelt-1 device
timeFrame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Secondary outcomes:
measure: Weight
timeFrame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
measure: Distance measurements
timeFrame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
measure: Circumference and "figure of eight"
timeFrame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
measure: Volume of the lower leg/foot
timeFrame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
measure: Medical grading of oedema
timeFrame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: Alexander Lyon, BCh PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chausiaux O, Williams G, Nieznanski M, Bagdu A, Downer P, Keyser M, Husheer S. Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume. Med Devices (Auckl). 2021 Apr 13;14:105-118. doi: 10.2147/MDER.S297713. eCollection 2021.