Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05193084 |
| Other study ID # |
MRI01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
March 15, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Heartfelt Technologies |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 is a cardinal feature of heart failure decompensation, though not all
patients seek medical attention at this time. The detection of this increase in volume may
therefore be a useful tool in preventing heart failure decompensation and hospitalisation.
This study will evaluate a completely automated (no contact) device which captures volumes of
the patient's feet in their home, with the ultimate aim of this data being accessible to the
heart failure team. However for the purpose of this study, the clinical team will be blinded
to the data in order to be able to assess the temporal relationship (and time) between an
alert being generated by the device and a hospital admission, or medication change. However
if for example a patient fall is detected by the device, a designated Manchester clinician
can be contacted to act.
Peripheral oedema is a cardinal feature of heart failure decompensation, though not all
patients seek medical attention at this time. The detection of this increase in volume may
therefore be a useful tool in preventing heart failure decompensation and hospitalisation.
In WS1 of the current study, the investigators will specifically be looking at whether the
use of the Heartfelt Technology can be used to support the remote monitoring of clinical
response to home-based intravenous(IV) diuretic interventions as part of an admission
avoidance strategy. Our hypothesis is that the Heartfelt technology coupled with this home
intervention could provide clinically useful objective measurement of peripheral oedema,
which could be used by the heart failure team to titrate the diuretics and guide duration of
treatment.
This pilot study will examine change in longitudinal volumes measured by the device and home
IV diuretic dosage as well as daily clinical observations. This will help confirm the
validity of the readings provided by the device.
Once the home-based intravenous(IV) diuretic intervention is complete, patients will continue
to be monitored for a total of 3 months, to observe relative stability or detect further
clinically significant decompensations.
In WS2 of the current study, the investigators will be looking at whether Heartfelt alert can
offer a window of opportunity in which to perform a theoretical clinical intervention. In
order to establish the lead time, recently discharged patients, a population known to be at
high risk of re-admission, will be provided with the Heartfelt device and a post-hoc analysis
of the data will be performed to establish the number of days between the alert being raised
by the Heartfelt device and the date of diagnosis of decompensation +/- hospital admission
where this occurs.
This study will be a small-scale pilot to collect information which will support the set-up
of a larger study. The pilot will be purely observational as the investigators will not
intervene based on the Heartfelt readings. The post-hoc analysis will be undertaken to inform
the design of the larger study. As soon as a patient has had the device disconnected, their
data can be reviewed for analysis as their participation in the study is completed at that
point. This may allow for preliminary analysis to be completed part way through the wider
study.
During the pilot the investigators will also collect acceptability ratings from patients and
carers.
Research in Heart failure has been reported to often recruit non representative patient
groups (Younger patients generally and fewer women and BAME patients than expected for
example). So the investigators plan to compare data from the study participants to the ones
of the overall HF population seen at the hospital (already recorded as part of the NICOR
records). The demographic that the investigators plan to compare are: deprivation level (from
postcode), age, sex and ethnicity.
