Foot Oedema Observed Over Time Study

NCT04072744 | Completed

• 1 other identifier: TSD01
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 5

Brief Summary

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 laboratory study 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.

Conditions

Heart Failure; Edema Leg

Keywords

Peripheral oedema; Peripheral edema; Heart failure; Decompensation; Weight; Hospital admissions

Outcome Measures

Primary Outcomes (1)

• Change in foot volume prior to Heart failure related hospital admission

  The primary outcome is the change in foot volume between baseline and the last observed foot volume measurement prior to hospital admission for a given patient. This will aim to demonstrate the ability of the heartfelt system to provide advance warning of impending hospitalisation.

  Through study completion, an average of 6 months

Secondary Outcomes (2)

• Frequency of data collection by the Heartfelt Device

  Through study completion, an average of 6 months

• Correlation between foot volume and significant medical intervention

  Through study completion, an average of 6 months

Study Arms (1)

Participants

General Study Participants

Device: Heartfelt measurements; Device: Connected weighing scales

Interventions

Heartfelt measurements DEVICE

The measurements taken using the Heartfelt device do not require contact with the participant. For the measurements to take place, the participant will simply walk in the field of view of the device. As the device(s) will have been installed at a location allowing the best view of where the participant goes in an out of bed, the participant is not expected to change anything to their routine. The device can also take measurements in the dark, so if the participant walks in front of the device in the dark, this information will also be captured. The Heartfelt device is a CE (European Conformity) marked product. Neither the participant, or the medical team will be able to see the data collected by the Heartfelt device during the study. They will be blinded to the data until each participant has completed the study. At that point they can choose to review the data from participant individually or wait until all the data from all participants is available.

Participants

Connected weighing scales DEVICE

The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional. The weighing scales display weight so that the participants can record the weight in their own heart failure records. The participant will be able to see the weight readings on the weighing scales during the study. The scales will communicate with the Personal Computer (PC) contained in the Heartfelt device and the data will be sent to the Heartfelt server through an encrypted link.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally resident patients who are under the care of the cardiology / heart failure team with a high risk for heart failure related hospital admission, are potentially eligible.

You may qualify if:

• Patients age 18 years or older.
• Patient able, agrees and signs the Informed Consent Form.
• Patient with any heart failure diagnosis.
• Patient under the care of a cardiologist with heart failure nurse care.
• Patient with one prolonged inpatient stay
• Patient with significant peripheral oedema at admission
• Patient with significant weight loss following admission (at least 5kg weight loss).
• Patient has been discharged on at least furosemide 80mg or Bumetanide 2mg/d

You may not qualify if:

• Patient has bandages everyday
• Patient has an amputation of the foot
• Patient lacks capacity to consent
• Patient is of no fixed abode
• Patient has plans for intervention (CRT, Valves)
• Patient taking part in another study
• Patient must not been pregnant, and is taking relevant birth control\*
• Note that criteria (g) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (participants are expected to be over 55 years old).

Sponsors & Collaborators

• Heartfelt Technologies: lead
• Torbay and South Devon NHS Foundation Trust: collaborator

Study Sites (5)

Bedfordshire Hospitals NHS Foundation Trust

Luton, Bedfordshire, LU4 0DZ, United Kingdom

Location

North Tees and Hartlepool Hospitals NHS Foundation Trust

Stockton-on-Tees, County Durham, TS19 8PE, United Kingdom

Location

Torbay and South Devon NHS Foundation Trust

Torquay, Devon, TQ27AA, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

North Shields, Northumbria, NE29 8NH, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Body Weight

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Phil Keeling, MD

  Torbay and South Devon NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: December 11, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)