Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787380
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2021-03-03
Brief Title:
Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure
Sponsor:
Heartfelt Technologies
Organization:
Heartfelt Technologies
Study Overview
Official Title:
Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure LOVE-HF Double Blinded Pilot Randomised Controlled Cross-over Trial
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOVE-HF
Brief Summary:
Patients with heart failure HF who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide or equivalentday will be recruited for the LOVE-HF trial at Blackpool Victoria Hospital
Eligible participants will be randomized to use the Heartfelt Device alongside standard care weighing symptom reporting or standard care alone Participants and clinicians will be blinded double blind as to which arm participants are in and after 30 days participants will be crossed over to the other arm This can be done without disrupting patients as the Heartfelt device can be switched remotely from a technical checks only mode to a full data analysis mode and vice versa The investigators aim to recruit 30 participants for the pilot study The study will also run in parallel with its sister pilot trial LOVE-HF-2
Through this study we are testing the capability to get the answers from patients healthcare systems and devices in order to inform future clinical trial design
Eligible participants will be randomized to use the Heartfelt Device alongside standard care weighing symptom reporting or standard care alone Participants and clinicians will be blinded double blind as to which arm participants are in and after 30 days participants will be crossed over to the other arm This can be done without disrupting patients as the Heartfelt device can be switched remotely from a technical checks only mode to a full data analysis mode and vice versa The investigators aim to recruit 30 participants for the pilot study The study will also run in parallel with its sister pilot trial LOVE-HF-2
Through this study we are testing the capability to get the answers from patients healthcare systems and devices in order to inform future clinical trial design
Detailed Description:
Heart Failure is the final common pathway of most forms of cardiovascular disease In the United Kingdom UK it affects around 900 000 people causes or complicates around 5 of adult emergency hospital admissions and consumes up to 2 of total National Health Service NHS expenditure An important part of discharge planning includes measures such as early follow up in order to prevent readmissions The hallmark of heart failure is fluid retention and between 2009 and 2016 43 to 50 of hospital admissions were associated with peripheral oedema Therefore early recognition of this and treatment of the congestion may prevent hospital admissions In clinical trials management strategies have included patient education telemedicine and remote monitoring The main non-invasive method for detecting fluid retention has been the use of weight as a surrogate marker
The Heartfelt device is an invention that uses a system of cameras in a compact device in order to generate 3 dimensional images of the feet and lower legs The volumes can then be calculated and thus changes in amount of peripheral oedema can be estimated In a clinical trial NCT02993601 performed by the Heart Failure team at the Royal Brompton Hospital there was good correlation between measurements made by Heartfelt and a water displacement method The resolution was as good as 20mls
By positioning the Heartfelt device in the bedroom automatic measurements can be made whenever the subject gets in and out of bed Images 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 companys secure servers Personal identifiable data participant name address age is stored on an encrypted hard drive along with linkage information device serial numbers to associate the participant identifiable data with the data captured in the home Therefore data collection is not only secure but entirely passive which is a major advantage compared with previous non-invasive methods and it is applicable to a very wide range of compliant and non-compliant patients
Our hypothesis is that the Heartfelt device can directly detect the increase in peripheral oedema associated with heart failure decompensation and that on average the number of days with missing data collected by the Heartfelt device will be lower than that of the weighing scales
Blackpool Victoria Hospital provides acute heart failure service both for in-patients and out-patients including capacity to administer parenteral furosemide in hospital cardiac day case unit community or home settings
Participants with chronic heart failure will be monitored in their home using the Heartfelt device experimental arm only Participants in both arms will also receive standard care Standard care means that participants will be encouraged to report symptoms and weigh themselves on a regular basis as per the recommendation of their doctor or heart failure nurse reporting them without delay This will be done in line with current advice given to heart failure patients locally which is that patients should record their weight in a diary and seek urgent medical attention if their weight goes up by at least 2 to 3 pounds in 24 hours or 5 pounds or more in one week or if they notice an increase in leg swelling andor an increase in breathlessness
Participants will be provided with electronic internet connected weighing scales that can transmit weight data These weighing scales will be used as per the usual advice given to patients thus taking part in the study should not change their behaviour Temporal changes in weight and volume will be compared Research questionnaires will also be used to estimate the quality of life mental wellbeing and hope status of participants and collect feedback on the device and study design
The Heartfelt device is an invention that uses a system of cameras in a compact device in order to generate 3 dimensional images of the feet and lower legs The volumes can then be calculated and thus changes in amount of peripheral oedema can be estimated In a clinical trial NCT02993601 performed by the Heart Failure team at the Royal Brompton Hospital there was good correlation between measurements made by Heartfelt and a water displacement method The resolution was as good as 20mls
By positioning the Heartfelt device in the bedroom automatic measurements can be made whenever the subject gets in and out of bed Images 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 companys secure servers Personal identifiable data participant name address age is stored on an encrypted hard drive along with linkage information device serial numbers to associate the participant identifiable data with the data captured in the home Therefore data collection is not only secure but entirely passive which is a major advantage compared with previous non-invasive methods and it is applicable to a very wide range of compliant and non-compliant patients
Our hypothesis is that the Heartfelt device can directly detect the increase in peripheral oedema associated with heart failure decompensation and that on average the number of days with missing data collected by the Heartfelt device will be lower than that of the weighing scales
Blackpool Victoria Hospital provides acute heart failure service both for in-patients and out-patients including capacity to administer parenteral furosemide in hospital cardiac day case unit community or home settings
Participants with chronic heart failure will be monitored in their home using the Heartfelt device experimental arm only Participants in both arms will also receive standard care Standard care means that participants will be encouraged to report symptoms and weigh themselves on a regular basis as per the recommendation of their doctor or heart failure nurse reporting them without delay This will be done in line with current advice given to heart failure patients locally which is that patients should record their weight in a diary and seek urgent medical attention if their weight goes up by at least 2 to 3 pounds in 24 hours or 5 pounds or more in one week or if they notice an increase in leg swelling andor an increase in breathlessness
Participants will be provided with electronic internet connected weighing scales that can transmit weight data These weighing scales will be used as per the usual advice given to patients thus taking part in the study should not change their behaviour Temporal changes in weight and volume will be compared Research questionnaires will also be used to estimate the quality of life mental wellbeing and hope status of participants and collect feedback on the device and study design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None