Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot

NCT04787393 | Completed DMC

• 1 other identifier: BTH01.2
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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 in the LOVE-HF-2 trial at Blackpool Victoria Hospital. The main objective of the study is to test if the Heartfelt device is sensitive to change across the full range of the individual patient's oedema. The participants will be given the Heartfelt device to use in their home. This device automatically and passively measures patient's foot and lower leg's volume without the patient having to remember to do anything. The patients will be seen face to face with a cardiologist to evaluate peripheral oedema using standard clincial technics as well as overall congestion level. The investigators aim to recruit 30 participants for the observational pilot study. The study follows its sister pilot trial, LOVE-HF (NCT04787380).

Conditions

Heart Failure

Keywords

Heart Failure; Edema leg; Quality of life; Hospital Admissions; Days alive out of hospital; Heartfelt Device; Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• Foot volume measured by the Heartfelt device in the home.

  1-6 months

• Foot volume measured by the Heartfelt device in the hospital.

  1-6 months

Secondary Outcomes (9)

• Patient weight measured in hospital.

  1-6months

• Oedema/Edema scores

  1-6months

• Left ventricular ejection fraction

  1-6months

• Left atrial volume

  1-6months

• Diastolic function (E/A, E/E')

  1-6months

Study Arms (1)

LOVE-HF-2 Participants

Participants will have the Heartfelt device as well as a set of weighing scales installed at home. Alerts will be raised for the patient to be seen at home or in clinic by clinician ( the clinician will be blinded to the type of alert). During this face-to-face encounter, the clinician will perform a detailed oedema assessment (recording pitting depth, time of recovery, height oedema, overall grading), ankle circumference measurement, weight measurements, and echo (Left ventricular ejection fraction, Left atrial volumes, inferior vena cava diameter, Diastolic function (E/A, E/E'), TAPSE and TR jet velocity + visually estimated mitral and tricuspid regurgitation).

Device: Heartfelt device; Device: Connected weighing scales

Interventions

Heartfelt device DEVICE

The Heartfelt device uses a system of scanner in a compact device to generate depth images of the feet and lower legs with a view to detecting early volume changes. The device can be installed on the wall or as a free standing unit, For the measurements to take place, the participant walks in the field of view of the device, measurments are only taken when the patients has bare feet and no slippers/shoes, so the location of the device in the home is choosen to match this requirement. Participants are not expected to change anything to their routine. The device can also take measurements in the dark.

LOVE-HF-2 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 if they wish to do so. 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. The data from the scales will be reviewed retrospectively, as the comparison in this study is with standard care, not with enhanced provision of care, which would be the case if we were using automatic reporting of weights.

LOVE-HF-2 Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will be chosen to be close representatives of the target population for the device: Heart failure patients at high risk of decompensation, with associated peripheral oedema.

You may qualify if:

• Patients with HF who recently (\< 6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) who are treated with at least 80 mg furosemide (or equivalent) orally per day Patients with HF older than 18 years Patients who took part in LOVE-HF can also be approached.
• 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 the value of the device beyond 1-2 months of decompensation.

You may not qualify if:

• 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 a 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 and/or impact clinical interventions and participant outcomes
• Participant must not be pregnant, and is taking relevant birth control if of child-bearing potential\*

Sponsors & Collaborators

• Heartfelt Technologies: lead
• Blackpool Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospital

Blackpool, Lancashire, FY3 9NR, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christopher Cassidy

  Blackpool Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: June 7, 2022
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)