Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure (LOVE-HF) Double Blinded Pilot Randomised Controlled Cross-over Trial
Trial ID: NCT04787380
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-03-05
Completion date: 2021-09-30
Sponsor: Heartfelt Technologies
Collaborators: Blackpool Teaching Hospitals NHS Foundation Trust
Conditions: Heart Failure
Interventions: Heartfelt device
Locations: Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust (Blackpool Victoria Hospital), Whinney Heys Road.
Countries: United Kingdom
Enrollment: 27
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 for the LOVE-HF trial at Blackpool Victoria Hospital.

Eligible participants will be randomized to use the Heartfelt Device alongside standard care (weighing + symptom reporting), or standard care alone. Participants and clinicians will be blinded (double blind) as to which arm participants are in, and after 30 days, participants will be crossed over to the other arm. This can be done without disrupting patients as the Heartfelt device can be switched remotely from a 'technical checks only' mode to a 'full data analysis' mode and vice versa. The investigators aim to recruit 30 participants for the pilot study. The study will also run in parallel with its sister pilot trial, LOVE-HF-2.

Through this study, we are testing the capability to get the answers from patients, healthcare systems, and devices, in order to inform future clinical trial design.

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) treated with at least 80 mg furosemide (or equivalent)/day.
* Patients with HF ≥18 years.

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

Outcomes:
Proportion of participants we can establish number of days alive out of hospital