Status:
COMPLETED
Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure
Lead Sponsor:
Heartfelt Technologies
Collaborating Sponsors:
Blackpool Teaching Hospitals NHS Foundation Trust
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equi...
Detailed Description
Heart Failure is the final common pathway of most forms of cardiovascular disease. In the United Kingdom (UK), it affects around 900 000 people, causes or complicates around 5% of adult emergency hosp...
Eligibility Criteria
Inclusion
- Patients with HF who recently (\<6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) treated with at least 80 mg furosemide (or equivalent)/day.
- Patients with HF ≥18 years.
- Note that the research team will try to include as many patients as possible in the month following discharge, however we will not exclude consideration of a small proportion of patients within 6 months of decompensation. This has the extra advantage of demonstrating value of the device beyond 1-2 months of decompensation.
Exclusion
- Inability to provide informed consent \*
- Participant has bandages to lower limbs everyday
- Participant has an amputation of the foot
- Participant is a regular wheelchair user
- Participant is of no fixed abode
- Participant has potentially reversible cause of decompensated heart failure and is awaiting urgent intervention (revascularisation/ valvular heart disease), which means the patient cannot be discharged for home-based care.
- Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation by and/or impact clinical interventions and participant outcomes.
- Participant must not be pregnant, and is taking relevant birth control if of child-bearing potential\*
- Note that a participant not able to comply with weighing is NOT an exclusion criteria as the Heartfelt Device should provide data for these participants despite their lack of ability to adhere to the usual monitoring protocol, and this is seen as one of the long term benefits that the device can provide.
- Note that the exclusion criteria (a) has been added as participants would need to be able to give individual responses to questionnaires, communicate directly with the Heartfelt team, etc.
- Note that the exclusion criteria (h) has been requested by the insurance for clinical trial cover.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04787380
Start Date
March 5 2021
End Date
September 30 2021
Last Update
March 21 2022
Active Locations (1)
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1
Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust (Blackpool Victoria Hospital), Whinney Heys Road.
Blackpool, Lancashire, United Kingdom, FY3 9NR