Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second (LOVE-HF-2)
Trial ID: NCT04787393
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-06-07
Completion date: 2022-10-26
Sponsor: Heartfelt Technologies
Collaborators: Blackpool Teaching Hospitals NHS Foundation Trust
Conditions: Heart Failure
Interventions: Heartfelt device; Connected weighing scales
Locations: Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospital
Countries: United Kingdom
Enrollment: 23
Age range: 18 Years - None
Sex: ALL

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).

Eligibility criteria:
Inclusion criteria:

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.

Exclusion Criteria:

1. Inability to provide informed consent\*
2. Participant has bandages to lower limbs everyday
3. Participant has an amputation of the foot
4. Participant is a regular wheelchair user
5. Participant is of no fixed abode
6. 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
7. 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
8. 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, or questionnaires 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.

* This exclusion criteria (a) has been added as participants would need to be able to communicate directly with the Heartfelt team, etc.
* This exclusion criteria (h) has been requested by the insurance provider for clinical trial cover.

Outcomes:
Foot volume measured by the Heartfelt device in the home.; Foot volume measured by the Heartfelt device in the hospital.