Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure
NCT ID: NCT05026034
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2021-09-23
2022-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Training Cohort
Inpatients with HF requiring \>24 hours IV diuretics
non-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
Cohort A
Patients undergoing serial, clinically indicated RHC. To investigate if measures derived by the CPM wearable device correlate with invasive measures of cardiopulmonary haemodynamics (PCWP).
non-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
Cohort B
Patients receiving haemodialysis. To investigate if changes in measures derived by the CPM wearable device correlate with B-lines on LUS and changes in B-lines before and after haemodialysis and with volume of fluid removed during haemodialysis
non-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
Cohort C
Patients receiving inpatient intravenous diuretic treatment for heart failure. To investigate if changes in measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound and weight before and after treatment for HF.
non-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
Interventions
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non-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
Eligibility Criteria
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Inclusion Criteria
* Male or female over18 years of age Cohort A
* Meet European Society of Cardiology 1 (ESC) criteria for diagnosis of HF
* Undergoing clinically-indicated RHC Cohort B
* Established on haemodialysis for \>90 days
* Undergoing haemodialysis with target volume removal ≥1.5 litres fluid Cohort C
* Meet ESC criteria for diagnosis of HF including heart failure
* Requiring treatment with intravenous (IV) diuretics Training Cohort
* Meet ESC criteria for diagnosis of HF including heart failure
* Requiring treatment with intravenous (IV) diuretics
Exclusion Criteria
* Allergies or skin sensitivities to silicone-based adhesive
* Skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed
* Pregnancy or breast-feeding
* Conditions that may confound congestion assessments
* COVID-19 infection.
18 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Pardeep Jhund
Role: PRINCIPAL_INVESTIGATOR
Glasgow University and NHS Greater Glasgow and Clyde
Locations
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Golden Jubilee National Hospital
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Countries
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Other Identifiers
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GN20CA003
Identifier Type: -
Identifier Source: org_study_id
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