Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393842
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-02-19
Brief Title:
Correlation of Non-invasive CPM Wearable Device With Measures of Congestion in Heart Failure in Exercise
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
Correlation of the Non-invasive Cardiopulmonary Management Wearable Device With Measures of Congestion in Heart Failure in Exercise - CONGEST - HF - EX
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONGEST-HFEX
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 patients 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
Analog Devices Inc have developed a wearable patch-like device called the Cardio- Pulmonary Management CPM wearable device which is applied to a patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None