134 Lancashire objective volume evaluation of leg oedema in heart failure randomized controlled cross-over trials (love-HF artificial intelligence research programme): rationale and methodology

Abstract

Introduction In England and Wales, heart failure (HF) was the primary diagnosis for >81,000 hospital admissions in 2016-17, with a 30-day readmission rate of nearly 20%. The National HF Audit reports that half of these admissions were associated with moderate or severe peripheral oedema. Conventionally, leg oedema is assessed and graded by a healthcare professional (HCP). A serial measurement of weight is an alternative method of assessing water retention at home but this relies on patient compliance.The Heartfelt device uses high-resolution cameras to generate 3D images of the lower legs and calculates volumes with a precision of about 20mLs without the need for active patient input. Linking Artificial Intelligence algorithms may then be applied to inform either the patient or a healthcare professional of appropriate actions.

Methods The Lancashire Objective Volume Evaluation of leg oedema in Heart Failure (LOVE-HF) artificial intelligence research programme consists of two pilot randomised controlled, cross-over trials (each with 30 patients and 30 day assessment periods), a registry and screening log (the latter to permit comparison of baseline characteristics to ensure generalisability).

Patients with HF who received IV diuretics (within <6 months) or with peripheral oedema despite receiving at least 80 mg/day of oral furosemide (or equivalent), will be enrolled in LOVE-HF (comparing the Heartfelt device on top of standard care to standard care: figure 1) and LOVE-HF-2 (comparing the Heartfelt device to weight monitoring: figure 2). The efficacy outcome of interest is ‘number of days alive out of hospital’. Secondary outcomes include serious adverse events, quality of life, mental wellbeing, hopelessness scores and HF-symptoms.