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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: non-invasive Cardiopulmonary Management (CPM) wearable device

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.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Queen Elizabeth University Hospital
  • Glasgow, United Kingdom, G81 4HX
    • Golden Jubilee National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Heart Failure

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training Cohort; Inpatients with HF requiring >24 hours IV diuretics	Device: non-invasive Cardiopulmonary Management (CPM) wearable device; non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
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).	Device: non-invasive Cardiopulmonary Management (CPM) wearable device; non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
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	Device: non-invasive Cardiopulmonary Management (CPM) wearable device; non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
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.	Device: non-invasive Cardiopulmonary Management (CPM) wearable device; non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: GN20CA003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be determined on completion of recruitment in line with sponsor policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No