Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure
- Conditions
- Heart Failure
- Interventions
- Device: non-invasive Cardiopulmonary Management (CPM) wearable device
- Registration Number
- NCT05026034
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A non-invasive Cardiopulmonary Management (CPM) wearable device 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 C non-invasive Cardiopulmonary Management (CPM) wearable device 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. Training Cohort non-invasive Cardiopulmonary Management (CPM) wearable device Inpatients with HF requiring \>24 hours IV diuretics Cohort B non-invasive Cardiopulmonary Management (CPM) wearable device 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
- Primary Outcome Measures
Name Time Method 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 volume of fluid removed by dialysis in mls
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 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
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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 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 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
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 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
Trial Locations
- Locations (2)
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom