Status:
UNKNOWN
Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure
Lead Sponsor:
Heartfelt Technologies
Collaborating Sponsors:
Manchester University NHS Foundation Trust
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This study will aim to collect proof of concept data to inform the study design of a larger paired comparison study to establish key research questions about the Heartfelt device. The current study wi...
Detailed Description
Heart failure hospitalisations are common, but some are potentially preventable through early detection and timely optimisation of pharmacotherapies, most often diuretic titration. Peripheral oedema ...
Eligibility Criteria
Inclusion
- Work stream 1
- Patient is willing and able to provide written informed consent.
- Diagnosis of heart failure
- Patient with peripheral oedema requiring IV diuretics
- Patient accepted for co-management by the MFT Heart Failure and home IV team\*
- There may be some instances where the patient is under the management of the MFT HF team but attends the day unit for IVs due to capacity or other logistical considerations. These patients can also be enrolled in the evaluation.
- Work stream 1
Exclusion
- Patient has bandages to lower limbs everyday
- Patient has an amputation of the foot
- Patient lacks capacity to consent
- Patient is not ambulant or unable to mobilise unaided around the house
- Patient is of no fixed abode
- Patient has potentially reversible cause of decompensated heart failure and is awaiting intervention (revascularisation/ valvular intervention)
- Patient taking part in a conflicting evaluation/study that could confound the results of this evaluation by and/or impact clinical interventions and patient outcomes
- Patient must not be pregnant, and is taking relevant birth control if of child-bearing potential\*
- Note that a patient not able to comply with daily weights is NOT an exclusion criteria as the Heartfelt Device should provide data for these patients despite their lack of ability to adhere to the usual monitoring protocol.
- \*Note that criteria (h) 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 (the typical age of patients is expected in an earlier evaluation was around 70 years ).
- Work stream 2 Inclusion Criteria:
- Patient is willing and able to provide written informed consent.
- Diagnosis of heart failure
- Patient under follow up with the MFT HF service
- Patient with a recent admission with decompensated heart failure in last 12 months OR who received home IV diuretics within the last 12-months
- Patient has been discharged on at least furosemide 80mg or equivalent diuretic dose
- Work stream 2
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 15 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05193084
Start Date
March 1 2022
End Date
March 15 2024
Last Update
May 3 2023
Active Locations (1)
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1
The Manchester Heart Centre Manchester University NHS Foundation
Manchester, United Kingdom