NCT04787380

Brief Summary

Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited for the LOVE-HF trial at Blackpool Victoria Hospital. Eligible participants will be randomized to use the Heartfelt Device alongside standard care (weighing + symptom reporting), or standard care alone. Participants and clinicians will be blinded (double blind) as to which arm participants are in, and after 30 days, participants will be crossed over to the other arm. This can be done without disrupting patients as the Heartfelt device can be switched remotely from a 'technical checks only' mode to a 'full data analysis' mode and vice versa. The investigators aim to recruit 30 participants for the pilot study. The study will also run in parallel with its sister pilot trial, LOVE-HF-2. Through this study, we are testing the capability to get the answers from patients, healthcare systems, and devices, in order to inform future clinical trial design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

March 3, 2021

Last Update Submit

March 18, 2022

Conditions

Heart Failure

Keywords

Heart FailureEdema LegQuality of lifeHospital AdmissionsDays alive out of hospitalHeartfelt DeviceArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants we can establish number of days alive out of hospital

    The proportion of participants for whom we can collect data to establish the number of days alive and out of hospital.

    60 days

Secondary Outcomes (12)

  • Proportion of participants we can establish number of days alive and well out of hospital

    60 days

  • Proportion of participants who complete study questionnaires

    60 days

  • True alerts - oedema

    60 days

  • True alerts - diuretics

    60 days

  • Proportion of participants we can establish date of emergency hospital admission which is HF related

    60 days

  • +7 more secondary outcomes

Other Outcomes (2)

  • Proportion of participants we can establish the number of days alive out of hospital in which the participant had significant weight gain

    60 days

  • Proportion of participants we can establish the number of days alive out of hospital in which the device did not capture adequate images of the foot to generate a volume

    60 days

Study Arms (2)

LOVE-HF Arm A (Full data analysis mode of Heartfelt + weight + symptoms reporting)

EXPERIMENTAL

Participants in LOVE-HF Arm A (Full data analysis mode of Heartfelt + weight + symptoms reporting) will not know if they are assigned to LOVE-HF Arm A or LOVE-HF Arm B. The Heartfelt device will be in 'full data analysis' mode and participants will follow standard care recommendations for weighing themselves and reporting their symptoms. 'Full data analysis' mode means that the device will be fully operational and will be detecting and reporting changes in foot volume over time. The device will have been allocated to the 'full data analysis' mode prior to shipping. Participants will be provided with electronic, internet connected weighing scales that can transmit weight data. These weighing scales will be used as per usual advice given to patients, thus taking part in the study should not change their behaviour.

Device: Heartfelt device

LOVE-HF Arm B (Technical checks only mode of Heartfelt + weight + symptoms reporting)

NO INTERVENTION

Participants in LOVE-HF Arm B (Technical checks mode of Heartfelt + weight + Symptoms reporting) will not know if they are assigned to LOVE-HF Arm A or LOVE-HF Arm B. The Heartfelt device will be in 'technical checks only' mode where the data analysis pipeline is blocked and changes in foot volume over time will not be processed or reported. However, technical checks on device functioning and image quality (e.g. camera being blocked) will be made as usual. The device will have been allocated to the 'technical checks only' mode prior to shipping. Participants will follow standard care recommendations for weighing themselves and reporting their symptoms. Participants will be provided with electronic, internet connected weighing scales that can transmit weight data. These weighing scales will be used as per usual advice given to patients, thus taking part in the study should not change their behaviour.

Interventions

Heartfelt deviceDEVICE

The Heartfelt device uses a system of cameras in a compact device to generate 3D images of the feet and lower legs with a view to detecting early volume changes. The device can be installed on the wall or as a free standing unit; however, given the COVID-19 pandemic, only the free standing option will be available to participants, so as to avoid the necessity of an installer visiting the patient. For the measurements to take place, the participant walks in the field of view of the device. Participants are not expected to change anything to their routine. The device can also take measurements in the dark. The switch between 'full data analysis' and 'technical checks only' modes can be done remotely, making the cross-over seamless. In the event that an alert is generated by the device, a medical assessment will take place either by phone or face to face appointment to evaluate the participant's condition.

LOVE-HF Arm A (Full data analysis mode of Heartfelt + weight + symptoms reporting)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with HF who recently (\<6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) treated with at least 80 mg furosemide (or equivalent)/day.
  • Patients with HF ≥18 years.
  • Note that the research team will try to include as many patients as possible in the month following discharge, however we will not exclude consideration of a small proportion of patients within 6 months of decompensation. This has the extra advantage of demonstrating value of the device beyond 1-2 months of decompensation.

You may not qualify if:

  • Inability to provide informed consent \*
  • Participant has bandages to lower limbs everyday
  • Participant has an amputation of the foot
  • Participant is a regular wheelchair user
  • Participant is of no fixed abode
  • Participant has potentially reversible cause of decompensated heart failure and is awaiting urgent intervention (revascularisation/ valvular heart disease), which means the patient cannot be discharged for home-based care.
  • Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation by and/or impact clinical interventions and participant outcomes.
  • Participant must not be pregnant, and is taking relevant birth control if of child-bearing potential\*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust (Blackpool Victoria Hospital), Whinney Heys Road.

Blackpool, Lancashire, FY3 9NR, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kenneth Wong, MA, DM, FRCP

    Blackpool Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants in both arms of the study will have the Heartfelt device installed. The Heartfelt device will be able to operate in two modes: "technical checks only" mode and "full data analysis" mode. Only participants in Arm A (Heartfelt device + weight + symptom reporting) will have the device in "full data analysis" mode. Participants in Arm B (weight + symptom reporting) will have the device in "technical checks only" mode where the data analysis pipeline will be blocked and therefore will not be detecting changes in foot volume. Only members of staff at Heartfelt Technologies not otherwise involved in the study will pre-set the devices in the relevant mode. The mode of the device will not be known by anyone in contact with the participants or the participants themselves. The switch between the two modes can be done remotely, to maintain blinding. The team will also receive alerts at random in the "technical checks only" mode to maintain blinding.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 8, 2021

Study Start

March 5, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)