ME-HF trial
Research type
Research Study
Full title
Monitoring oEdema in Heart Failure to Improve Function and Reduce Hospitalisation Risk (ME-HF)
IRAS ID
360123
Contact name
Fozia Ahmed
Contact email
Sponsor organisation
Heartfelt Technologies Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
This research aims to test whether a new monitoring system, called the Heartfelt device, can help improve care for patients with chronic heart failure. The Heartfelt device uses a camera placed in the home to passively measure changes in the volume of the feet and lower legs each day, without the need for patients to do anything special. These measurements help detect fluid build-up (oedema), which is a common sign of heart failure getting worse.
The trial will involve 300 participants from at least 15 NHS hospitals and GP groups across the UK. Participants will be randomly placed into one of two groups: one group will receive standard NHS care (including regular weight checks and symptom monitoring), and the other group will use the Heartfelt device in addition to standard care. If the Heartfelt device detects significant fluid build-up, healthcare teams will receive an alert so they can quickly intervene and adjust treatments if required.
The main aim of the study is to see if using the Heartfelt device reduces heart failure-related problems and improves patients' quality of life, as measured by a standard health questionnaire (EQ-5D-5L). Other important outcomes include checking how regularly the device sends useful data, tracking hospital admissions, monitoring medication adherence, and understanding what triggers clinical alerts.
Participants are expected to be mostly older adults experiencing moderate to severe oedema and reduced quality of life. The study will also ensure a diverse group of patients, aiming to include those from different geographic and social backgrounds, especially individuals who may have less access to healthcare services.
Alongside testing the effectiveness of the device, the study will carefully assess how easy it is to use and its overall economic impact. Patient involvement throughout the trial will help ensure that results are relevant and useful for future care strategies.REC name
London - Dulwich Research Ethics Committee
REC reference
25/PR/1023
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion