HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device (HF-TRACK)

Randomised Controlled Trial For Assessing The Effectiveness Of An Inclusive Heart Failure Monitoring And Tracking Solution In The UK.(HF-TRACK)

The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization.

Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly.

The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy.

This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Heartfelt Device installed; Other: Standard care; Other: Questionnaires; Device: Heartfelt Device in pharmacy; Device: Heartfelt device alerting system

Detailed Description

This study has been co-designed with existing and past users (patients and their carers) of the Heartfelt device who have in the past expressed an interest in sharing their opinion for future research.

It is a 6 months crossover randomised controlled trial designed to evaluate the effectiveness of the Heartfelt device, a remote patient monitoring system, in reducing the risk of hospitalisation for heart failure (HF) by monitoring peripheral oedema.

We will focus on patients with heart failure who have had at least one hospitalisation for heart failure associated with peripheral oedema in the last year, with stratified randomisation (for the RCT part) to avoid recent discharge effects in the early phases of data collection and focussing on patients considered at high-risk of poor long-term adherence to daily weights (the majority of patients with heart failure). [8-Fitzgerald].

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB22 3GN
    • Pillsorted Ltd
  • Hull, United Kingdom
    • James Alexander Family Practice
  • Hull, United Kingdom, HU7 4DW
    • DR GT Hendow Surgery
  • Hull, United Kingdom, HU7 4PT
    • Sutton Manor Pharma Services
  • London, United Kingdom, RM1 2BA
    • Barking, Havering and Redbridge University Hospitals NHS Trust
  • East Riding Of Yorkshire
    • Brough, East Riding Of Yorkshire, United Kingdom, HU15 1AY
      • The Ridings Medical Group
    • Hull, East Riding Of Yorkshire, United Kingdom, HU7 5DD
      • Dr R Raut & Partnership (General Practice)
  • London
    • Croydon, London, United Kingdom, CR7 7YE
      • Croydon Health Services NHS Trust
  • Suffolk
    • Bury St Edmunds, Suffolk, United Kingdom, IP33 2QZ
      • West Suffolk NHS Foundation Trust
  • Surrey
    • Horley, Surrey, United Kingdom, RH6 9PT
      • Modality East Surrey Medical Practice
  • West Yorkshire
    • Keighley, West Yorkshire, United Kingdom, BD21 1LA
      • Modality Partnership Airedale, Wharfedale & Craven:

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

In order to be eligible to participate in this trial, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form (e-consent via website or app is acceptable).
• Women or men, aged 18 years or older [No maximum age].
• Diagnosis of heart failure at least 3 months previously
• Receiving diuretics on a daily basis
• Peripheral oedema reported on at least one HF-related hospitalisation in the last 4 years (as documented in EPR).
• Hospitalised for HF OR on a Virtual Ward for HF OR has received IV diuretic treatment in the last 12 months, or treated with at least 80 mg furosemide (or equivalent) orally per day.
• For women of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study.
• Is considered by the investigator to be non-adherent OR at high risk of HF hospital readmissions.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

• bandages to lower limbs every day
• amputation of both feet
• regular wheelchair user inside their home
• bed-bound
• no fixed abode
• taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
• Pregnancy or lack of contraceptive measures if of child-bearing potential†
• 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

† This exclusion criterion has been requested by the insurance provider for clinical trial cover.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Care + Heartfelt device; In addition to standard care activities, participants have the Heartfelt device at home. During this arm, the device sends alerts and measurement data to the patient, carers and clinicians.	Device: Heartfelt Device installed; Device installed in the patient's home and capturing foot volume data which are processed in the cloud.; Other Names: Remote patient monitoring device; Other: 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.; Other Names: Daily weighing, Breathlessness, Dizziness, Tiredness; Other: Questionnaires; Patients are presented with one or more optional questionnaires (some validated, some bespoke); Other Names: 5Q-5D, Bespoke Questionnaires; Device: Heartfelt device alerting system; The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.; Other Names: Remote patient monitoring device
Active Comparator: Standard care (control); In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians.	Device: Heartfelt Device installed; Device installed in the patient's home and capturing foot volume data which are processed in the cloud.; Other Names: Remote patient monitoring device; Other: 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.; Other Names: Daily weighing, Breathlessness, Dizziness, Tiredness; Other: Questionnaires; Patients are presented with one or more optional questionnaires (some validated, some bespoke); Other Names: 5Q-5D, Bespoke Questionnaires
Experimental: Standard Care + Heartfelt device in pharmacy; Participants will follow standard care advice, and have monthly measurements taken at the pharmacy using the Heartfelt device. The pharmacist will receive the measurements and alerts and be able to communicate this to the participant.	Other: 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.; Other Names: Daily weighing, Breathlessness, Dizziness, Tiredness; Other: Questionnaires; Patients are presented with one or more optional questionnaires (some validated, some bespoke); Other Names: 5Q-5D, Bespoke Questionnaires; Device: Heartfelt Device in pharmacy; Device used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud.; Other Names: Monitoring device used in phamarcy; Device: Heartfelt device alerting system; The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.; Other Names: Remote patient monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality Rate.	This measure tracks the total number of participant deaths due to any cause during the study period. It is an essential indicator of overall participant survival and general safety of the treatment under investigation. This data is collected and verified through clinical records. Measure: The number of all-cause deaths documented in clinical records. Unit of Measure: Count of deaths.	Through study completion, an average of 6 months
Device-Related Complication Rate.	This measure captures the frequency of complications associated with the medical device used in the study. It includes any adverse events or malfunctions linked to the device, providing insight into its safety and performance. Measure: The incidence of complications related to the medical device in use, as specified in Sections 8.1.4 and 8.1.5 of the study protocol. Unit of Measure: Count of complication events.	Through study completion, an average of 6 months
Heart Failure Events Incidence.	This metric quantifies the number of times participants have heart failure events. The criteria for what constitutes a heart failure event are based on the definition provided by Abraham WT in 2020, ensuring standardised and specific event classification. Measure: The frequency of hospital events specifically for heart failure, as defined by Abraham WT, 2020. Unit of Measure: Count of heart failure events.	Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Admission Duration	Description: This measures the length of hospital stays, noting the admission and discharge dates. Measure: Length of Stay Unit of Measure: Days	Through study completion, an average of 6 months
Cause of Hospitalization	This identifies the primary reason for hospitalization. Measure: Cause Hospitalization Category Unit of Measure: Categorical.	Through study completion, an average of 6 months
Hospitalisation Admission Route	This identifies the route of admission during hospitalization events, such as ICU, CCU, or ward admission. Measure: Admission Route Unit of Measure: Categorical (ICU, CCU, Ward)	Through study completion, an average of 6 months
Loss of Independence	This assesses instances where a patient becomes unable to live at home, necessitating care in a facility. Measure: Change in Living Arrangements Unit of Measure: Binary (Independent, Dependent)	Through study completion, an average of 6 months
Scheduling of Care Events	This differentiates between scheduled and unscheduled care events. Measure: Nature of Scheduling Unit of Measure: Categorical (Scheduled, Unscheduled)	Through study completion, an average of 6 months
Setting of Care Events	This categorizes care events as either inpatient or outpatient. Measure: Care Setting Unit of Measure: Categorical (Inpatient, Outpatient)	Through study completion, an average of 6 months
Date of Changes in HF Medication Post-Discharge	This tracks the date of any change in heart failure medications after the patient returns home, excluding changes made during ward stays. Measure: Medication Adjustment Date Unit of Measure: Date (YYYY-MM-DD)	Through study completion, an average of 6 months
Changes in dosage of HF Medication Post-Discharge	This tracks the change(s) in dosage in heart failure medications after the patient returns home, excluding changes made during ward stays. Measure: Medication Adjustment Dosage Unit of Measure: % change from previous dosage.	Through study completion, an average of 6 months
Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices	This measures the variance in data availability, encompassing both device-generated and contemporaneous self-reported data. Measure: Degree of Variance Unit of Measure: Number of days per month with physiological measurements taken.	Through study completion, an average of 6 months
Timestamp of Health Alerts Generated by the Heartfelt Device	This measures the date and time of health alerts generated by the Heartfelt device. Measure: Timestamp of Health Alerts Unit of Measure: Date and time	Through study completion, an average of 6 months
Frequency of Health Alerts Generated by the Heartfelt Device	This measures the number of health alerts generated by the Heartfelt device over a specified period. Measure: Number of Health Alerts Unit of Measure: Count	Through study completion, an average of 6 months
Foot volume	This reports the foot volume reported by the Heartfelt device. Measure: Foot and lower leg volume Unit of Measure: mL	Through study completion, an average of 6 months
Weight	This measures the patient's weight Measure: patient weight Unit of Measure: Kg	Through study completion, an average of 6 months
Peripheral oedema grading	This reports the Peripheral oedema grading reported by the Heartfelt device. Measure: Peripheral oedema grading Heartfelt scale [0-None / 1-Mild (includes ankle, but no higher) / 2-Moderate (Above the ankle, up to and including the knee)/ 4-Severe (Above the knee)]	Through study completion, an average of 6 months
Cause of Death	This records the cause of death classified as related to heart failure (HF) or not, as defined in Abraham WT, 2020 . Measure: Cause of Death Unit of Measure: Date (YYYY-MM-DD)	Through study completion, an average of 6 months
Date of Death	This records the date of death classified as related to heart failure (HF) or not, as defined in Abraham WT, 2020 . Measure: Date of Death Unit of Measure: Categorical	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Heartfelt Technologies

Publications and helpful links

General Publications

• Abraham WT, Psotka MA, Fiuzat M, Filippatos G, Lindenfeld J, Mehran R, Ambardekar AV, Carson PE, Jacob R, Januzzi JL Jr, Konstam MA, Krucoff MW, Lewis EF, Piccini JP, Solomon SD, Stockbridge N, Teerlink JR, Unger EF, Zeitler EP, Anker SD, O'Connor CM. Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium. JACC Heart Fail. 2020 Dec;8(12):961-972. doi: 10.1016/j.jchf.2020.10.002. Epub 2020 Nov 13.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: peripheral oedema; Heart failure decompensation; Heart failure hospitalisation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Health Services Administration; Health Care Quality, Access, and Evaluation; Pharmaceutical Preparations; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Technology, Pharmaceutical; Standard of Care; Dosage Forms; Surveys and Questionnaires
• Other Study ID Numbers: HFT-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not decided yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No