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

NCT07067658 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Installation of Heartfelt Device

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

OTHER

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.

OTHER

Questionnaires

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

DEVICE

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.

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • University of Glasgow

    collaborator OTHER

  • Heartfelt Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2027-01-31
Completion
2027-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07067658 on ClinicalTrials.gov