Clinical trial NCT05026034: Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure
Official title: Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2021-08-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Heart Failure

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure
timeFrame: 3 months
measure: Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
timeFrame: 4 hours
measure: Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
timeFrame: 4 hours
measure: Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and clinical measures of congestion
timeFrame: 24 hours
measure: Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
timeFrame: 24 hours
Secondary outcomes:
measure: Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry
timeFrame: 24 hours
measure: Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry
timeFrame: 24 hours
measure: Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry
timeFrame: 24 hours
measure: Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score
timeFrame: 3 months
measure: Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score
timeFrame: 4 hours
measure: Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score
timeFrame: 24 hours
measure: Cohort A: To determine the correlation between congestion measured by the CPM wearable device and right heart catheter (RHC) measurements
timeFrame: 3 months
measure: Cohort A: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
timeFrame: 3 months
measure: Cohort B: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
timeFrame: 4 hours
measure: Cohort C: To determine the correlation between congestion measured by the CPM wearable device and echocardiography
timeFrame: 24 hours
Other outcomes:
measure: Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP
timeFrame: 3 months
measure: Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP
timeFrame: 4 hours
measure: Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and NTproBNP
timeFrame: 24 hours
measure: Cohort A: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct)
timeFrame: 3 months
measure: Cohort B: Correlation coefficient between congestion score measured by CPM wearable device and change in haematocrit (Hct)
timeFrame: 4 hours
measure: Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and Change in haematocrit (Hct)
timeFrame: 24 hours
measure: Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left ventricular strain
timeFrame: 3 months
measure: Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and right ventricular strain
timeFrame: 4 hours
measure: Cohort C: Correlation coefficient between congestion score measured by CPM wearable device and left atrial strain
timeFrame: 24 hours
Locations:
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: Glasgow University and NHS Greater Glasgow and Clyde
name: Pardeep Jhund
role: PRINCIPAL_INVESTIGATOR
References: