Correlation of Non-invasive CPM Wearable Device With Measures of Congestion in Heart Failure in Exercise

NCT06393842 | Recruiting FDA Device

• 1 other identifier: INGN22CA411
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid status and congestion can be determined by the CPM wearable device and correlates with non-invasive measures and biochemical markers of congestion and changes in congestion.

Conditions

Heart Failure

Keywords

Pulmonary Congestion

Outcome Measures

Primary Outcomes (2)

• To investigate if changes in measures derived by the CPM wearable device correlate with changes in B-lines between dialysis sessions and with the difference in weight between dialysis sessions.

  Correlation of change in congestion measured by the CPM wearable device (thoracic impedance and S3) and change in lung ultrasound (LUS) and weight between the end of the dialysis session and the start of the subsequent dialysis session in patients undergoing two consecutive hemodialysis sessions.

  Between Two Consecutive Dialysis Session (Day 1 and Day 3)

• To investigate if measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound before and after exercise during the treatment for HF.

  To compare correlations of congestion measured by the CPM wearable device (thoracic impedance and S3) and clinical measures of congestion (LUS) in inpatients with HF obtained before and after exercise

  Data will be gathered at four time points: (1) on the day of enrolment; (2) the day after enrolment; (3) within 24 hours of switch from IV to oral diuretics and; (4) when the patient is as euvolemic as reasonably achievable

Secondary Outcomes (2)

• To determine the correlation between change in pulmonary function measured by the CPM wearable device and change in pulmonary function measured with spirometry between two consecutive dialysis sessions.

  Between Two Consecutive Dialysis Session (Day 1 and Day 3)

• To compare the correlations, before and after exercise, between congestion measured by the CPM wearable device (thoracic impedance and S3) and TTE findings.

  Data will be gathered at four time points: (1) on the day of enrolment; (2) the day after enrolment; (3) within 24 hours of switch from IV to oral diuretics and; (4) when the patient is as euvolemic as reasonably achievable

Study Arms (2)

Cohort A

Patients receiving hemodialysis: Primary Objective is to investigate if changes in measures derived by the CPM wearable device correlate with changes in B-lines between dialysis sessions and with the difference in weight between dialysis sessions. The end point would be to demonstrate a change in number of B-Lines on Lung Ultrasound between dialysis sessions and compare it with changes in measures derived by CPM wearable device (thoracic impedance and S3) taken during the same sessions. We would then use correlation coefficient to find how strong a relationship is between measures from Lung Ultrasound and CPM wearable device. Secondary objective will include correlation of the measures from CPM wearable device with other measures of congestion including Spirometry, Echocardiography, Biomarkers and Physical symptoms and signs including EVEREST and ASCEND congestion score

Device: Cardiopulmonary Management Wearable Device

Cohort B

Primary Objective- Patients receiving inpatient intravenous diuretic treatment for heart failure. To investigate if measures derived by the CPM wearable device system correlate with B-lines on lung ultrasound before and after exercise during the treatment for HF. The end point would be to demonstrate a change in number of B-Lines on LUS before and after exercise during decongestion treatment for HF and compare it with measures derived by CPM wearable device (thoracic impedance and S3) taken during the same sessions. We would then use correlation coefficient to find how strong a relationship is between measures from LUS and CPM wearable device and whether the correlation improved following exercise. Secondary objective will include correlation of the measures from CPM wearable device with other measures of congestion including Spirometry, Echocardiography, Biomarkers and Physical symptoms and signs including EVEREST and ASCEND congestion score

Device: Cardiopulmonary Management Wearable Device

Interventions

Cardiopulmonary Management Wearable Device DEVICE

Fluid status and congestion can be determined by the CPM wearable device and correlates with non-invasive measures and biochemical markers of congestion and changes in congestion.

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort A- Dialysis patients (Inpatients and Outpatients) at the Queen Elizabeth University Hospital, Glasgow Cohort B- Heart Failure Hospitalizations at the Queen Elizabeth University Hospital

You may qualify if:

• Written informed consent Male or female ≥18 years of age
• Cohort A
• Established on hemodialysis for \>90 days
• Undergoing hemodialysis with target volume removal ≥1.5 liters fluid
• Cohort B Meet ESC criteria for diagnosis of Heart Failure including
• Heart failure with reduced (HF-REF), mid-range (HF-mREF) and preserved (HF-PEF) ejection fractions
• Requiring treatment with intravenous (IV) diuretics

You may not qualify if:

• 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
• Currently uncontrolled cardiac arrhythmia
• Hemodynamically significant mitral stenosis (at least moderate in severity on TTE)
• Conditions that may confound congestion assessments including
• A. Severe obstructive lung disease B. Severe fibrotic lung disease C. Severe liver disease D. Relevant active malignancy E. Active viral or bacterial bronchopneumonia-CXR within 4 weeks showing consolidation F. Pulmonary contusion G. Pneumothorax H. Pneumonectomy I. Lobectomy J. Pulmonary embolism within the previous 3 months K. Indwelling intercostal chest drain L. Left ventricular assist device (LVAD) M. COVID-19 infection. N. Increased Body Mass Index where satisfactory Echocardiographic images not possible
• Cohort B only - inability to perform exercise safely

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Analog Devices: collaborator

Study Sites (1)

Glasgow Cardiovascular Research Centre

Glasgow, Scotland, G12 8TA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Pardeep Jhund, FRCP, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivasankar Murugan Sukumar, MBBS, MRCP

CONTACT

+44 141 330 2677; Shivasankar.MuruganSukumar@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: May 1, 2024
• Study Start: March 22, 2024
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

GB (1)