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

NCT06334822 | Active Not Recruiting DMC

• 1 other identifier: HFT-2024-01
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Heart Failure

Keywords

peripheral oedema; Heart failure decompensation; Heart failure hospitalisation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Cause of Death

  Through study completion, an average of 6 months

• Date of Death

  Through study completion, an average of 6 months

• Hospital Admission Duration

  Through study completion, an average of 6 months

• Cause of Hospitalization

  Through study completion, an average of 6 months

• Hospitalisation Admission Route

  Through study completion, an average of 6 months

Study Arms (3)

Standard Care + Heartfelt device

EXPERIMENTAL

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; Other: Standard care; Other: Questionnaires; Device: Heartfelt device alerting system

Standard care (control)

ACTIVE COMPARATOR

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; Other: Standard care; Other: Questionnaires

Standard Care + Heartfelt device in pharmacy

EXPERIMENTAL

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; Other: Questionnaires; Device: Heartfelt Device in pharmacy; Device: Heartfelt device alerting system

Interventions

Standard care OTHER

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.

Also known as: Daily weighing, Breathlessness, Dizziness, Tiredness

Standard Care + Heartfelt device; Standard Care + Heartfelt device in pharmacy; Standard care (control)

Heartfelt Device installed DEVICE

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

Also known as: Remote patient monitoring device

Standard Care + Heartfelt device; Standard care (control)

Questionnaires OTHER

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

Also known as: 5Q-5D, Bespoke Questionnaires

Standard Care + Heartfelt device; Standard Care + Heartfelt device in pharmacy; Standard care (control)

Heartfelt Device in pharmacy DEVICE

Device used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud.

Also known as: Monitoring device used in phamarcy

Standard Care + Heartfelt device in pharmacy

Heartfelt device alerting system DEVICE

The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.

Also known as: Remote patient monitoring device

Standard Care + Heartfelt device; Standard Care + Heartfelt device in pharmacy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heartfelt Technologies: lead

Study Sites (11)

The Ridings Medical Group

Brough, East Riding Of Yorkshire, HU15 1AY, United Kingdom

Location

Dr R Raut & Partnership (General Practice)

Hull, East Riding Of Yorkshire, HU7 5DD, United Kingdom

Location

Croydon Health Services NHS Trust

Croydon, London, CR7 7YE, United Kingdom

Location

West Suffolk NHS Foundation Trust

Bury St Edmunds, Suffolk, IP33 2QZ, United Kingdom

Location

Modality East Surrey Medical Practice

Horley, Surrey, RH6 9PT, United Kingdom

Location

Modality Partnership Airedale, Wharfedale & Craven:

Keighley, West Yorkshire, BD21 1LA, United Kingdom

Location

Pillsorted Ltd

Cambridge, CB22 3GN, United Kingdom

Location

DR GT Hendow Surgery

Hull, HU7 4DW, United Kingdom

Location

Sutton Manor Pharma Services

Hull, HU7 4PT, United Kingdom

Location

James Alexander Family Practice

Hull, United Kingdom

Location

Barking, Havering and Redbridge University Hospitals NHS Trust

London, RM1 2BA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33199251 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care; Surveys and Questionnaires; Dosage Forms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Pharmaceutical Preparations; Technology, Pharmaceutical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only outcomes assessors will be blinded.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This 6-month study involves up to 210 patients using the Heartfelt device at home. It is a crossover trial with a 21-day break between two 69-day periods to prevent overlap effects. Patients will either receive standard care or standard care plus Heartfelt alerts. The Heartfelt group is further divided into three 23-day sub-studies to test different alert systems. Another 60 patients will have monthly measurements taken at the pharmacy without being part of the main randomisation.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (11)