Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure

UnknownOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

March 1, 2022

Primary Completion Date

January 14, 2024

Study Completion Date

March 15, 2024

Conditions
Heart Failure
Interventions
DEVICE

Heartfelt Device

"The Heartfelt Device is a CE marked device that measures the volume of the foot/lower leg. By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Feet identification software, complemented by manual checks, ensures that photographs are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. For this study, no personal identifiable data will be stored on the device or on the servers used by the device.~The volume readings collected can be presented to the clinical team on a web interface. This is not presented against identifiable data, but only participant ID. However, in the current pilot, volume readings will not be reviewed by the clinical team until the point of data analysis, after the study period."

DEVICE

Connected weighing scales

"The connected weighing scales are Xiaomi Smart Scales (CE marked, manufactured by Anhui Huami Informeyshn Technologies).~The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional(s) (the fact that a participant has not used scales regularly in the past is not an exclusion criteria). The weighing scales display weight so that the participants can record the weight in their own heart failure records (paper weight diary).~The study team will check the patient's paper weight diary in case they choose to use another set of scales.~The participant will be able to see the weight readings on the weighing scales during the study.~The scales will record patient weight as well as the date and time of the measurements."

Trial Locations (1)

Unknown

The Manchester Heart Centre Manchester University NHS Foundation, Manchester

Sponsors
All Listed Sponsors
collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

lead

Heartfelt Technologies

INDUSTRY

NCT05193084 - Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure | Biotech Hunter | Biotech Hunter