Status:
COMPLETED
Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot
Lead Sponsor:
Heartfelt Technologies
Collaborating Sponsors:
Blackpool Teaching Hospitals NHS Foundation Trust
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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
- Inclusion criteria:
- Patients with HF who recently (\< 6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) who are treated with at least 80 mg furosemide (or equivalent) orally per day Patients with HF older than 18 years Patients who took part in LOVE-HF can also be approached.
- 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 the value of the device beyond 1-2 months of decompensation.
- Exclusion Criteria:
- 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 a 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 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, or questionnaires 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.
- This exclusion criteria (a) has been added as participants would need to be able to communicate directly with the Heartfelt team, etc.
- This exclusion criteria (h) has been requested by the insurance provider for clinical trial cover.
Exclusion
Key Trial Info
Start Date :
June 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 26 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04787393
Start Date
June 7 2022
End Date
October 26 2022
Last Update
October 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospital
Blackpool, Lancashire, United Kingdom, FY3 9NR