Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure

NCT05193084 | Completed

• 1 other identifier: MRI01
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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 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

Keywords

Heart Failure; Oedema; Heartfelt Device

Outcome Measures

Primary Outcomes (4)

• Use of the device to optimise drug management

  Can the volumes measured by the Heartfelt device be useful in titrating and optimising drug management for patients undergoing home-IV diuretics? (WS1)

  3 months

• Use of the device to monitor heart failure stability and detect fluid overload

  Can the Heartfelt device can be used to monitor heart failure stability and detect fluid overload in patients recently discharged after an episode of decompensated heart failure? (WS2)

  3 months

• Response to device by patients

  Is the device well received by patients?

  3 months

• Response to device by carers

  Is the device well received by carers?

  3 months

Secondary Outcomes (1)

• Number of days prior to hospital admission the device can detect changes in foot volume

  3 months

Study Arms (2)

Work Stream 1 (WS1)

The general aim of this work stream is to assess the hypothesis "can the volumes measured by the Heartfelt device be useful in titrating and optimising drug management for patients undergoing home-IV diuretics and after completion of IV-diuretic treatment.?" We will characterise the data collected by the Heartfelt device in the participants' home, correlating it to weight readings (either from the scales or paper weight diary) and medical observations recorded while patients are being treated with IV Diuretics. Patients from WS1 will be invited to keep the device in their home for 3 months in total, which will therefore cover periods during which they do not receive IV diuretics, but are still at relatively high risk of decompensation. That data will be analysed in the same fashion as the data collected in WS2.

Device: Heartfelt Device; Device: Connected weighing scales

Work Stream 2 (WS2)

The general aim of WS2 is to assess the hypothesis "can the Heartfelt device be used to monitor heart failure stability and detect fluid overload in patients recently discharged after an episode of decompensated heart failure?". This work stream will also aim to examine whether the Heartfelt device gives an indication of the number of days prior to hospital admissions that the Heartfelt device can detect changes in foot volume. This will be achieved by comparing the data collected by the Heartfelt device in the participants' home, and correlating it to weight readings and medical observations. Hospital admissions will be a particularly useful correlation point as it would provide information on the detection of the forming oedema leading up to this event. In future, the information collected during this study will be used to design and power an interventional study to demonstrate the effectiveness of such data in providing a leading indicator of hospitalisation.

Device: Heartfelt Device; Device: Connected weighing scales

Interventions

Heartfelt Device 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.

Work Stream 1 (WS1); Work Stream 2 (WS2)

Connected weighing scales DEVICE

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.

Work Stream 1 (WS1); Work Stream 2 (WS2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients must be aged 18 years or older with a diagnosis of heart failure at the time of signing the informed consent form and be under the care of the Heart Failure service at Manchester University NHS Foundation Trust.

You may qualify if:

• 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.

You may not qualify if:

• 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 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 ).
• 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
• Patient has bandages everyday

Sponsors & Collaborators

• Heartfelt Technologies: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

The Manchester Heart Centre Manchester University NHS Foundation

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Edema

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Fozia Ahmed, MBChB

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 14, 2022
• Study Start: March 1, 2022
• Primary Completion: May 13, 2023
• Study Completion: June 13, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

GB (1)