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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training Cohort | Inpatients with HF requiring >24 hours IV diuretics |
| |
| 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). |
| |
| 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 |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive Cardiopulmonary Management (CPM) wearable device | Device | non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP | Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml | 3 months |
| Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP |
Inclusion Criteria:
Written informed consent
Exclusion Criteria:
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Patients with Heart Failure
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| Name | Affiliation | Role |
|---|---|---|
| Pardeep Jhund | Glasgow University and NHS Greater Glasgow and Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Jubilee National Hospital | Glasgow | G81 4HX | United Kingdom | |||
| Queen Elizabeth University Hospital |
To be determined on completion of recruitment in line with sponsor policy
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Blood samples will be taken for future cardiac biomarker analysis
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 |
Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml |
| 4 hours |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml | 24 hours |
| Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) | Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L | 3 months |
| Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) | Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L | 4 hours |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct) | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct) measured in L/L | 24 hours |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain measured in percentage by echocardiography | 3 months |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain measured in percentage by echocardiography | 4 hours |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain measured in percentage by echocardiography | 24 hours |
| Glasgow |
| United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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