Heart FailureHF-TRACKNCT06334822
HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device
A study testing Heartfelt Device installed, Questionnaires and Heartfelt Device in pharmacy in people with Heart Failure, run by Heartfelt Technologies at 11 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heartfelt Device installed, Questionnaires and Heartfelt Device in pharmacy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 11 Jul 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
The Ridings Medical Group
Brough, East Riding Of Yorkshire, HU15 1AY
West Suffolk NHS Foundation Trust
Bury St Edmunds, Suffolk, IP33 2QZ
Pillsorted Ltd
Cambridge, CB22 3GN
Croydon Health Services NHS Trust
Croydon, London, CR7 7YE
Modality East Surrey Medical Practice
Horley, Surrey, RH6 9PT
Dr R Raut & Partnership (General Practice)
Hull, East Riding Of Yorkshire, HU7 5DD
DR GT Hendow Surgery
Hull, HU7 4DW
Sutton Manor Pharma Services
Hull, HU7 4PT
James Alexander Family Practice
Hull
Modality Partnership Airedale, Wharfedale & Craven:
Keighley, West Yorkshire, BD21 1LA
Barking, Havering and Redbridge University Hospitals NHS Trust
London, RM1 2BA
About this study
Official title: 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.
Read more
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.
Read the 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].
- Conditions
- Heart Failure
- Being tested
- Heartfelt Device installed, Standard care, Questionnaires, Heartfelt Device in pharmacy, Heartfelt device alerting system
- Keywords
- peripheral oedema, Heart failure decompensation, Heart failure hospitalisation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartfelt Device installedDevice
Also called Remote patient monitoring device
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Standard careOther
Also called Daily weighing, Breathlessness, Dizziness, Tiredness
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.
QuestionnairesOther
Also called 5Q-5D, Bespoke Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt Device in pharmacyDevice
Also called Monitoring device used in phamarcy
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 systemDevice
Also called Remote patient monitoring device
The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Standard care; Other: Questionnaires; Device: Heartfelt Device in pharmacy; Device: Heartfelt device alerting system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (16)
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)
Measured: 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
Measured: Through study completion, an average of 6 months
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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 6 months
Weight
This measures the patient's weight Measure: patient weight Unit of Measure: Kg
Measured: 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)]
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start11 Jul 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartfelt Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334822
- Sponsor's protocol ID
- HFT-2024-01
- Acronym
- HF-TRACK
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33199251
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial For Assessing The Effectiveness Of An Inclusive Heart Failure Monitoring And Tracking Solution In The UK.(HF-TRACK)
- ClinicalTrials.gov ID
- NCT06334822
- Acronym / sponsor ID
- HF-TRACK / HFT-2024-01
- Conditions
- Heart Failure
- Keywords
- peripheral oedema, Heart failure decompensation, Heart failure hospitalisation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Heartfelt TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care + Heartfelt device | Experimental | Device: Heartfelt Device installed, Other: Standard care, Other: Questionnaires, Device: Heartfelt device alerting systemIn 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 | Device: Heartfelt Device installed, Other: Standard care, Other: QuestionnairesIn 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 | Other: Standard care, Other: Questionnaires, Device: Heartfelt Device in pharmacy, Device: Heartfelt device alerting systemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heartfelt Device installedAlso: Remote patient monitoring deviceDevice installed in the patient's home and capturing foot volume data which are processed in the cloud. | Device | Standard Care + Heartfelt device, Standard care (control) |
| Standard careAlso: Daily weighing, Breathlessness, Dizziness, TirednessPatients 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 | Standard Care + Heartfelt device, Standard Care + Heartfelt device in pharmacy, Standard care (control) |
| QuestionnairesAlso: 5Q-5D, Bespoke QuestionnairesPatients are presented with one or more optional questionnaires (some validated, some bespoke) | Other | Standard Care + Heartfelt device, Standard Care + Heartfelt device in pharmacy, Standard care (control) |
| Heartfelt Device in pharmacyAlso: Monitoring device used in phamarcyDevice used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud. | Device | Standard Care + Heartfelt device in pharmacy |
| Heartfelt device alerting systemAlso: Remote patient monitoring deviceThe Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals. | Device | Standard Care + Heartfelt device, Standard Care + Heartfelt device in pharmacy |
Primary outcome
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.
16 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 33199251Abraham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heartfelt Device installed, Questionnaires and Heartfelt Device in pharmacy in people with Heart Failure, run by Heartfelt Technologies at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality Rate. (time frame: Through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.