Clinical trial NCT06393842: Correlation of Non-invasive CPM Wearable Device With Measures of Congestion in Heart Failure in Exercise
Official title: Correlation of the Non-invasive Cardiopulmonary Management Wearable Device With Measures of Congestion in Heart Failure in Exercise - CONGEST - HF - EX
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Pulmonary Congestion
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Analog Devices
First posted: 2024-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Detailed description: Heart Failure is common, affecting 1-2% of the general population, with the prevalence increasing to over 10% in those over the age of 80. Heart Failure is associated with high morbidity, with many patients requiring frequent and often lengthy hospitalization for treatment with intra venous diuretics. In the recent Heart Failure audit of England and Wales, of over 68000 patients admitted to hospital with a primary diagnosis of Heart Failure between 2017 and 2018, median length of stay was 6-9 days, depending on whether patients were managed by specialist cardiologists. Heart Failure hospitalizations account for approximately 5% of all emergency admissions leading to 2% of all NHS inpatient bed-days. Heart Failure accounts for almost 2% of the total NHS budget, with approximately 70% of these costs due to Heart Failure hospitalizations. The hallmark of decompensation is the development of congestion. This is usually manifested by the development or worsening of pulmonary edema or peripheral edema. Patients often present to hospital when the degree of congestion becomes severe enough to cause symptoms, most often shortness of breath, and therefore require treatment through decongestion with vasodilators and intra venous diuretics. However, a number of studies have shown that the presence of congestion can be detected days to weeks prior to hospitalization leaving a window of opportunity in which treatment aimed at averting a costly hospitalization could occur. Furthermore, congestion can be altered by exercise and may be more pronounced on exercise. Detecting these early signs of congestion has so far only been possible using invasive monitoring devices such as specially designed pacemakers (Heart Logic™, Boston Scientific) or implantable pressure monitors (Cardio MEMS™, Abbott)

Analog Devices Inc have developed a wearable patch-like device called the Cardio- Pulmonary Management (CPM) wearable device which is applied to a patient's chest to assess congestion levels by measuring a number of physiological parameters over approximately five minutes. The goal of this Prospective Uncontrolled Clinical Investigation is to determine if the CPM wearable device can accurately detect the presence of congestion by correlating the findings from the device with changes in congestion status in patients receiving hemodialysis (Cohort A) and if the correlations are different before and after exercise in patients receiving treatment for decongestion for heart failure as an inpatient (Cohort B) as measured by lung spirometry, lung ultrasound Trans Thoracic Echocardiography and Biomarkers

Eligibility criteria: Inclusion Criteria:

Written informed consent Male or female ≥18 years of age

Cohort A

1. Established on hemodialysis for \>90 days
2. Undergoing hemodialysis with target volume removal ≥1.5 liters fluid

Cohort B Meet ESC criteria for diagnosis of Heart Failure including

1. Heart failure with reduced (HF-REF), mid-range (HF-mREF) and preserved (HF-PEF) ejection fractions
2. Requiring treatment with intravenous (IV) diuretics

Exclusion Criteria:

1. Unable to consent to inclusion in study due to cognitive impairment
2. Allergies or skin sensitivities to silicone- based adhesive
3. Skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed
4. Pregnancy or breast-feeding
5. Currently uncontrolled cardiac arrhythmia
6. Hemodynamically significant mitral stenosis (at least moderate in severity on TTE)
7. 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

Primary outcomes:
measure: 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.
timeFrame: Between Two Consecutive Dialysis Session (Day 1 and Day 3)
measure: 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.
timeFrame: 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:
measure: 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.
timeFrame: Between Two Consecutive Dialysis Session (Day 1 and Day 3)
measure: To compare the correlations, before and after exercise, between congestion measured by the CPM wearable device (thoracic impedance and S3) and TTE findings.
timeFrame: 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
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Cardiovascular Research Centre
state: Scotland
Study officials:
affiliation: University of Glasgow
name: Pardeep Jhund, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References: