Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK.

Heart Failure Clinical Trial

— HF-TRACK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334822
• Other study ID #: HFT-2024-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Heartfelt Technologies
• Contact: Oriane E Chausiaux, PhD
• Phone: +44 1223 967250
• Email: HF-TRACK[@]hftech.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 has received IV diuretic treatment in the last 12 months.

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.

In addition, at least 10 patients with a CardioMEMS, Heartlogic device or other implanted device capable of making physiological measurements designed to prevent admission for heart failure.

In line with the NIHR INCLUDE guidance27 , the study team will endeavour to include patients representative of the patients with heart failure in the UK, including, but not restricted to, ethnic minorities and a similar number of women and men.

Patients with or without a reduced left ventricular ejection fraction can be enrolled.

Patients who are unable to give consent due to impaired capacity can still participate in the study, provided that either a Personal Consultee or a Nominated Consultee is engaged in accordance with the Mental Capacity Act 2005 (MCA). Additionally, it is required that the researcher responsible for enrolling these patients has received training on how to obtain consent in such circumstances.

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

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

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

Locations

Country	Name	City	State
United Kingdom	Dr R Raut & Partnership (General Practice)	Hull	East Riding Of Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Heartfelt Technologies

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	Heart Failure Hospitalisation Incidence.	This metric quantifies the number of times participants are admitted to the hospital due to heart failure. The criteria for what constitutes a heart failure hospitalisation are based on the definition provided by Hicks KA in 2017, ensuring standardised and specific event classification.; Measure: The frequency of hospital admissions specifically for heart failure, as defined by Hicks KA, 2017.; Unit of Measure: Count of heart failure hospitalisation events.	6 months
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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	6 months
Secondary	Cause of Hospitalization	This identifies the primary reason for hospitalization. Measure: Cause Hospitalization Category Unit of Measure: Categorical.	6 months
Secondary	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)	6 months
Secondary	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.	6 months
Secondary	Cause of Death	This records the cause of death classified as related to heart failure (HF) or not, as defined in Hicks KA, 2017.; Measure: Cause of Death Unit of Measure: Date (YYYY-MM-DD)	6 months
Secondary	Date of Death	This records the date of death classified as related to heart failure (HF) or not, as defined in Hicks KA, 2017.; Measure: Date of Death Unit of Measure: Categorical	6 months
Secondary	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)	6 months
Secondary	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)	6 months
Secondary	Scheduling of Care Events	This differentiates between scheduled and unscheduled care events. Measure: Nature of Scheduling Unit of Measure: Categorical (Scheduled, Unscheduled)	6 months
Secondary	Setting of Care Events	This categorizes care events as either inpatient or outpatient. Measure: Care Setting Unit of Measure: Categorical (Inpatient, Outpatient)	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	Foot volume	This reports the foot volume reported by the Heartfelt device. Measure: Foot and lower leg volume Unit of Measure: mL	6 months
Secondary	Peripheral oedema grading	This reports the Peripheral oedema grading reported by the Heartfelt device. Measure: Peripheral oedema grading Heartfelt scale	Unit of Measure: 1-4 scale
Secondary	Weight	This measures the patient's weight Measure: patient weight Unit of Measure: Kg	6 months