Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure

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 Work Stream 1 (WS1) is expected to give an indication of the usefulness of the volumes measured by the Heartfelt device in optimising diuretic therapy for patients undergoing ambulatory-IV diuretic treatment, 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 Work Stream 2 (WS2), patients recently discharged after a heart failure hospitalisation (HFH), is expected to determine 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. The investigators may also be able to get an indication of the number of days prior to hospital admission during which the Heartfelt device can detect changes in foot volume.

Both workstreams will provide qualitative feedback, from health care practitioners, patients and carers in both groups about their experience using the Heartfelt Device.

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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Heartfelt Technologies

  lead INDUSTRY

Principal Investigators

• Dr Fozia Ahmed, MBChB · Manchester University NHS Foundation Trust

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2023-05-13

Completion

2023-06-13

Countries

• United Kingdom

Study Locations