Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Installation of Heartfelt Device

    Device

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

  • Enhanced Standard care

    Other intervention

    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

    Other intervention

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

  • Heartfelt device alerting system

    Device

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Enhanced Standard Care + Heartfelt DeviceExperimental treatment 4 interventions
Group B: Enhanced Standard Care (Control)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Composite Clinical Events

Unplanned hospital attendance (clinic, emergency, or admission) or death due to heart failure, cardiovascular, respiratory, or renal causes. Recurrent events will be included and adjudicated, providing a comprehensive measure of clinical deterioration over 12 months.

Time frame
Over 12-months period.
2

Health-Related Quality of Life (EQ-5D-5L)

Patient-reported quality of life measured using EQ-5D-5L, collected at baseline and follow-up (3, 6, 9, 12 months), with primary analysis at 12 months. This validated instrument captures overall health status across five domains and includes a visual analogue scale. * Measured using the EQ-5D-5L index * Collected at baseline, 3, 6, 9, and 12 months. * Primary time point: 12 months. EQ-5D-5L responses will be converted to utility scores on a scale from -0.59 to 1, where 1 represents the best health state, using the UK EQ-5D-5L value set. Patients with at least two or more utility scores during follow-up will be included in the analysis.

Time frame
Collected at baseline, 3, 6, 9, and 12 months

Secondary outcomes

1

Days Lost to Hospitalisation or Death

Total number of days lost due to hospitalisation for cardiovascular, respiratory, or renal conditions, or due to all-cause mortality.

Time frame
Over 12-months period.
2

Daily Data Availability

Proportion of days with successful data capture from the Heartfelt device and weighing scales, based on device-generated records or contemporaneous self-report.

Time frame
Over 12-months period.
3

Guideline-Recommended Medication Score

Adherence to guideline-recommended heart failure medications will be assessed using a guideline-recommended medication score, calculated at 3, 6, 9, and 12 months and averaged across these time points. The score is based on the number of eligible medication classes prescribed, with 1 point assigned per class (e.g., ACEi/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist \[MRA\]). The score ranges from 0 to 3, with 3 being the optimal medication score. The score is adjusted for patient eligibility: will be calculated only for patients with heart failure with reduced ejection fraction (HFrEF).

Time frame
Over 12-months period.
4

All-Cause Hospitalisations

Number of hospitalisations from any cause, analysed as recurrent events and adjusted for the competing risk of death.

Time frame
Over 12-months period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heartfelt Technologies

Lead sponsor

Manchester University NHS Foundation Trust

Collaborator

University of Glasgow

Collaborator

Source ClinicalTrials.gov
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