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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-23

Study Completion Date

2022-07-22

Brief Summary

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Fluid status and congestion can be determined by the CPM wearable device and correlates with invasive measures, non-invasive measures and biochemical markers of congestion and changes in congestion.

Detailed Description

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HF is associated with frequent and lengthy hospitalisations. These hospitalisations are usually as a result of congestion. The signs of congestion that can be recognised by physicians or health care professionals such as lung crackles or worsening of peripheral oedema are often seen at a late stage before an intervention can be made to prevent overt decompensation and admission to hospital. Recognising changes in excess fluid status either before a patient becomes unwell or during decongestion treatment is highly desirable so that timely treatment can be started or so that treatment can be adjusted based on an individual's response to therapy. The ability to assess patients by applying a single, non-invasive device would potentially provide a useful tool for assessing a patient's congestion levels and allow patients with progressive deterioration to be identified earlier.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training Cohort

Inpatients with HF requiring \>24 hours IV diuretics

non-invasive Cardiopulmonary Management (CPM) wearable device

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Written informed consent

* 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

* Unable to consent to inclusion in study due to cognitive impairment
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GN20CA003

Identifier Type: -

Identifier Source: org_study_id

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