MONITORED-HF study
Research type
Research Study
Full title
Remote MONIToring Of ambulatory intRavEnous Diuretics in Heart Failure
IRAS ID
290512
Contact name
Fozia Ahmed
Contact email
Sponsor organisation
Heartfelt Technologies Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research 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 will be run with 2 parallel workstreams. Both are presented here.
Data collected from WS1 is designed to examine the usefulness of the volumes measured by the Heartfelt device in optimising diuretic therapy for patients undergoing ambulatory-IV diuretics, as well as looking at the usefulness of foot volume changes monitoring post IV diuretic treatment. As these patients are often managed in a home / community setting objective indicators to assess oedema during treatment are currently limited.
Data collected from WS2, patients recently discharged after a heart failure hospitalisation (HFH), will examine if the Heartfelt device can be used to monitor heart failure stability and detect fluid overload in patients recently discharged from hospital after an episode of decompensated heart failure.
This pilot study will also provide qualitative feedback, from health care practitioners, patients and carers in both groups about their experience using the Heartfelt Device.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/PR/0485
Date of REC Opinion
1 Jun 2021
REC opinion
Further Information Favourable Opinion