Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeartfelt Technologies
About this trial
This study will evaluate the Heartfelt device, a novel, passive monitoring system that detects early signs of fluid build-up in patients (oedema) with heart failure by measuring changes in foot and lower leg volume through capture of 3D images. The trial will assess whether this device, when added to standard NHS care, improves quality of life and reduces heart failure-related events compared to standard care alone.
Eligibility criteria
Qualifiers
Aged ≥18 years, AND
Diagnosis of heart failure (any aetiology or LVEF classification), AND
Documented or patient-reported moderate to severe leg oedema, AND
Lives in the UK with a home environment suitable for installation of the Heartfelt device
Disqualifiers
Amputation of both feet
Bed-bound for more than 20h per 24h period
Bandages to lower limbs every day
Regular wheelchair user inside their home
Trial design
Treatments tested in this trial
- Installation of Heartfelt Device
- Enhanced Standard care
- Questionnaires
- Heartfelt device alerting system
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Heartfelt Technologies
Lead sponsor
Manchester University NHS Foundation Trust
Collaborator
University of Glasgow
Collaborator
Source ClinicalTrials.gov