300
Participants
Start Date
September 1, 2025
Primary Completion Date
October 31, 2026
Study Completion Date
February 29, 2028
Installation of Heartfelt Device
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Enhanced Standard care
Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. They should also report changes in breathlessness, tiredness and other symptoms associated with heart failure decompensation. At the start of the study, they will be reminded (or told) about the importance of self-checks and will be handed a patient booklet (from the British Heart Foundation) to standardise patients' knowledge.
Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt device alerting system
The Heartfelt device sends alerts on the active comparator arm to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.
Lead Sponsor
Manchester University NHS Foundation Trust
OTHER_GOV
University of Glasgow
OTHER
Heartfelt Technologies
INDUSTRY