Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure

Study Overview
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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.

Official Title
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Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: non-invasive Cardiopulmonary Management (CPM) wearable device


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training Cohort<br>Inpatients with HF requiring >24 hours IV diuretics | Device: non-invasive Cardiopulmonary Management (CPM) wearable device<br>* non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure<br>|
| Cohort A<br>Patients undergoing serial, clinically indicated RHC. To investigate if measures derived by the CPM wearable device correlate with invasive measures of cardiopulmonary haemodynamics (PCWP). | Device: non-invasive Cardiopulmonary Management (CPM) wearable device<br>* non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure<br>|
| Cohort B<br>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 | Device: non-invasive Cardiopulmonary Management (CPM) wearable device<br>* non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure<br>|
| Cohort C<br>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. | Device: non-invasive Cardiopulmonary Management (CPM) wearable device<br>* non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure | Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure measured in mmHg | 3 months | 
| Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) | Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) measured as change in number of B lines | 4 hours | 
| Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) | Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and volume of fluid removed by dialysis in mls | 4 hours | 
| Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and clinical measures of congestion | Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and change in weight (kg) | 24 hours | 
| Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) | Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) measured as change in number of B lines | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry | Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) | 24 hours | 
| Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry | Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) | 24 hours | 
| Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry | Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) | 24 hours | 
| Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score | Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score grading 0 to 3 (with 0 being absent or a trace) | 3 months | 
| Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score | Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score grading 0 to 3 (with 0 being absent or a trace) | 4 hours | 
| Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score | Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score grading 0 to 3 (with 0 being absent or a trace) | 24 hours | 
| Cohort A: To determine the correlation between congestion measured by the CPM wearable device and right heart catheter (RHC) measurements | Cohort A: To determine the correlation between congestion measured by the CPM wearable device and right heart catheter (RHC) measurements | 3 months | 
| Cohort A: To determine the correlation between congestion measured by the CPM wearable device and echocardiography | Cohort A: To determine the correlation between congestion measured by the CPM wearable device and left ventricular ejection fraction (LVEF) measured as a percentrage by echocardiography | 3 months | 
| Cohort B: To determine the correlation between congestion measured by the CPM wearable device and echocardiography | Cohort B: To determine the correlation between congestion measured by the CPM wearable device and left ventricular ejection fraction (LVEF) measured as a percentrage by echocardiography | 4 hours | 
| Cohort C: To determine the correlation between congestion measured by the CPM wearable device and echocardiography | Cohort C: To determine the correlation between congestion measured by the CPM wearable device and left ventricular ejection fraction (LVEF) measured as a percentrage by echocardiography | 24 hours |