Heart Failure
Conditions
Brief summary
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
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.
Interventions
DEVICEnon-invasive Cardiopulmonary Management (CPM) wearable device
non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
Sponsors
University of Glasgow
NHS Greater Glasgow and Clyde
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure | 3 months | Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure measured in mmHg |
| Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) | 24 hours | 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 |
| Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and clinical measures of congestion | 24 hours | Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and change in weight (kg) |
| Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) | 4 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry | 24 hours | Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) |
| Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry | 24 hours | Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) |
| Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry | 24 hours | Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry measured by tidal volumes (ml/kg) |
| Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score | 3 months | 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) |
| Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score | 4 hours | 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) |
| Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score | 24 hours | 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) |
| 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 right heart catheter (RHC) measurements |
| Cohort A: To determine the correlation between congestion measured by the CPM wearable device and echocardiography | 3 months | 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 |
| Cohort B: To determine the correlation between congestion measured by the CPM wearable device and echocardiography | 4 hours | 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 |
| Cohort C: To determine the correlation between congestion measured by the CPM wearable device and echocardiography | 24 hours | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct) | 24 hours | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct) measured in L/L |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain | 3 months | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain measured in percentage by echocardiography |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain | 4 hours | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain measured in percentage by echocardiography |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain | 24 hours | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain measured in percentage by echocardiography |
| Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP | 4 hours | Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml |
| Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) | 4 hours | Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L |
| Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP | 3 months | Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml |
| Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) | 3 months | Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct) measured in L/L |
| Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP | 24 hours | Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP measured in pg/ml |
Countries
United Kingdom
Outcome results
None listed