Status:
ACTIVE_NOT_RECRUITING
HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device
Lead Sponsor:
Heartfelt Technologies
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 failur...
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...
Eligibility Criteria
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.
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2027
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT06334822
Start Date
July 11 2024
End Date
January 31 2027
Last Update
March 16 2026
Active Locations (11)
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1
The Ridings Medical Group
Brough, East Riding Of Yorkshire, United Kingdom, HU15 1AY
2
Dr R Raut & Partnership (General Practice)
Hull, East Riding Of Yorkshire, United Kingdom, HU7 5DD
3
Croydon Health Services NHS Trust
Croydon, London, United Kingdom, CR7 7YE
4
West Suffolk NHS Foundation Trust
Bury St Edmunds, Suffolk, United Kingdom, IP33 2QZ