RecruitingNot ApplicableNCT07067658

Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk

Sponsor

Heartfelt Technologies

Enrollment

300 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

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

Min Age: 18 Years

Inclusion Criteria5

Adults \>18 years
Diagnosis of heart failure (any aetiology or left ventricular ejection fraction classification), any timeframe
Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic) for at least one month.
Heart failure hospital admission and moderate or severe leg oedema in the previous 12 months.
Lives in the UK, with a home environment suitable for installation of the Heartfelt device.

Exclusion Criteria13

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
No fixed abode
Participation in another interventional trial that may interfere with endpoints
Life expectancy \<6 months, in the opinion of the investigator
Inability to provide informed consent due to cognitive impairment
Language barriers that preclude understanding of trial procedures (unless translation resources are available in relevant language)
Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study.
Patients with severe aortic stenosis or awaiting a heart procedure or surgery
Patient with end stage renal disease (eGFR \<20)
Pregnancy or lack of contraceptive measures if of child-bearing potential

Interventions

DEVICEInstallation of Heartfelt Device

Device installed in the patient's home and capturing foot volume data which are processed in the cloud.

OTHEREnhanced 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.

OTHERQuestionnaires

Patients are presented with one or more optional questionnaires (some validated, some bespoke)

DEVICEHeartfelt 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.