Status:
COMPLETED
Foot Oedema Observed Over Time Study
Lead Sponsor:
Heartfelt Technologies
Collaborating Sponsors:
Torbay and South Devon NHS Foundation Trust
Conditions:
Heart Failure
Edema Leg
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
This is a phase 2 observational study during which Subjects with chronic heart failure will be monitored in their home using the Heartfelt device. The participant inclusion criteria will be those pat...
Eligibility Criteria
Inclusion
- Patients age 18 years or older.
- Patient able, agrees and signs the Informed Consent Form.
- Patient with any heart failure diagnosis.
- Patient under the care of a cardiologist with heart failure nurse care.
- Patient with one prolonged inpatient stay
- Patient with significant peripheral oedema at admission
- Patient with significant weight loss following admission (at least 5kg weight loss).
- Patient has been discharged on at least furosemide 80mg or Bumetanide 2mg/d
Exclusion
- Patient has bandages everyday
- Patient has an amputation of the foot
- Patient lacks capacity to consent
- Patient is of no fixed abode
- Patient has plans for intervention (CRT, Valves)
- Patient taking part in another study
- Patient must not been pregnant, and is taking relevant birth control\*
- Note that criteria (g) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (participants are expected to be over 55 years old).
Key Trial Info
Start Date :
December 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04072744
Start Date
December 11 2019
End Date
December 30 2022
Last Update
February 2 2023
Active Locations (5)
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1
Bedfordshire Hospitals NHS Foundation Trust
Luton, Bedfordshire, United Kingdom, LU4 0DZ
2
North Tees and Hartlepool Hospitals NHS Foundation Trust
Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE
3
Torbay and South Devon NHS Foundation Trust
Torquay, Devon, United Kingdom, TQ27AA
4
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE3 9QP