RecruitingNCT06393842

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

Correlation of the Non-invasive Cardiopulmonary Management Wearable Device With Measures of Congestion in Heart Failure in Exercise - CONGEST - HF - EX

Sponsor

NHS Greater Glasgow and Clyde

Enrollment

60 participants

Start Date

Mar 22, 2024

Study Type

OBSERVATIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria9

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
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

Interventions

DEVICECardiopulmonary Management Wearable 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.