--- title: "HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device" nct_id: NCT06334822 overall_status: ACTIVE_NOT_RECRUITING phase: NA sponsor: Heartfelt Technologies study_type: INTERVENTIONAL primary_condition: Heart Failure countries: United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06334822.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06334822" ct_last_update_post_date: 2026-03-16 last_seen_at: "2026-05-12T07:09:04.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device **Official Title:** Randomised Controlled Trial For Assessing The Effectiveness Of An Inclusive Heart Failure Monitoring And Tracking Solution In The UK.(HF-TRACK) **NCT ID:** [NCT06334822](https://clinicaltrials.gov/study/NCT06334822) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 186 - **Lead Sponsor:** Heartfelt Technologies - **Conditions:** Heart Failure - **Start Date:** 2024-07-11 - **Completion Date:** 2027-01-31 - **CT.gov Last Update:** 2026-03-16 ## 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. ## 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). \[8-Fitzgerald\]. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **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. - **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. - **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. ## Interventions - **Heartfelt Device installed** (DEVICE) — Device installed in the patient's home and capturing foot volume data which are processed in the cloud. - **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. - **Questionnaires** (OTHER) — Patients are presented with one or more optional questionnaires (some validated, some bespoke) - **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. - **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. ## Primary Outcomes - **All-Cause Mortality Rate.** _(time frame: Through study completion, an average of 6 months)_ — 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. - **Device-Related Complication Rate.** _(time frame: Through study completion, an average of 6 months)_ — 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. - **Heart Failure Events Incidence.** _(time frame: Through study completion, an average of 6 months)_ — 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. ## Secondary Outcomes - **Cause of Death** _(time frame: Through study completion, an average of 6 months)_ - **Date of Death** _(time frame: Through study completion, an average of 6 months)_ - **Hospital Admission Duration** _(time frame: Through study completion, an average of 6 months)_ - **Cause of Hospitalization** _(time frame: Through study completion, an average of 6 months)_ - **Hospitalisation Admission Route** _(time frame: Through study completion, an average of 6 months)_ - **Loss of Independence** _(time frame: Through study completion, an average of 6 months)_ - **Scheduling of Care Events** _(time frame: Through study completion, an average of 6 months)_ - **Setting of Care Events** _(time frame: Through study completion, an average of 6 months)_ - **Date of Changes in HF Medication Post-Discharge** _(time frame: Through study completion, an average of 6 months)_ - **Changes in dosage of HF Medication Post-Discharge** _(time frame: 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** _(time frame: Through study completion, an average of 6 months)_ - **Timestamp of Health Alerts Generated by the Heartfelt Device** _(time frame: Through study completion, an average of 6 months)_ - **Frequency of Health Alerts Generated by the Heartfelt Device** _(time frame: Through study completion, an average of 6 months)_ - **Foot volume** _(time frame: Through study completion, an average of 6 months)_ - **Weight** _(time frame: Through study completion, an average of 6 months)_ - **Peripheral oedema grading** _(time frame: Through study completion, an average of 6 months)_ ## Locations (11) - The Ridings Medical Group, Brough, East Riding Of Yorkshire, United Kingdom - Dr R Raut & Partnership (General Practice), Hull, East Riding Of Yorkshire, United Kingdom - Croydon Health Services NHS Trust, Croydon, London, United Kingdom - West Suffolk NHS Foundation Trust, Bury St Edmunds, Suffolk, United Kingdom - Modality East Surrey Medical Practice, Horley, Surrey, United Kingdom - Modality Partnership Airedale, Wharfedale & Craven:, Keighley, West Yorkshire, United Kingdom - Pillsorted Ltd, Cambridge, United Kingdom - DR GT Hendow Surgery, Hull, United Kingdom - Sutton Manor Pharma Services, Hull, United Kingdom - James Alexander Family Practice, Hull, United Kingdom - Barking, Havering and Redbridge University Hospitals NHS Trust, London, United Kingdom ## Recent Field Changes (last 30 days) - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.the ridings medical group|brough|east riding of yorkshire|united kingdom` — added _(2026-05-12)_ - `locations.dr r raut & partnership (general practice)|hull|east riding of yorkshire|united kingdom` — added _(2026-05-12)_ - `locations.croydon health services nhs trust|croydon|london|united kingdom` — added _(2026-05-12)_ - `locations.west suffolk nhs foundation trust|bury st edmunds|suffolk|united kingdom` — added _(2026-05-12)_ - `locations.modality east surrey medical practice|horley|surrey|united kingdom` — added _(2026-05-12)_ - `locations.modality partnership airedale, wharfedale & craven:|keighley|west yorkshire|united kingdom` — added _(2026-05-12)_ - `locations.pillsorted ltd|cambridge||united kingdom` — added _(2026-05-12)_ - `locations.dr gt hendow surgery|hull||united kingdom` — added _(2026-05-12)_ - `locations.sutton manor pharma services|hull||united kingdom` — added _(2026-05-12)_ - `locations.james alexander family practice|hull||united kingdom` — added _(2026-05-12)_ - `locations.barking, havering and redbridge university hospitals nhs trust|london||united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06334822.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06334822* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*