Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459999
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-03
Brief Title:
Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
BIO-CONGEST
Brief Summary:
The goal of this study is to test the accuracy of new blood and urine tests in people with heart failure The main question it aims to answer is
- Do new blood and urine tests correlate with fluid status This will be determined by comparison to routine and gold-standard tests in a range of patients with heart failure
- Do new blood and urine tests correlate with fluid status This will be determined by comparison to routine and gold-standard tests in a range of patients with heart failure
Detailed Description:
Heart failure HF is a common condition that is associated with recurrent and prolonged hospital admissions hospitalisation HF hospitalisation is associated with poor outcomes and therefore the identification of patients at risk of HF hospitalisation and avoidance of these events is of great importance
HF hospitalisations are frequently preceded by a period of increasing congestion pressure elevation within heart chambers and excess body fluid The identification of congestion can be difficult Current tests have limitations and signs of congestion such as lung crackles or leg swelling that can be recognised by health care professionals are often seen at a late stage before an intervention can be made to prevent hospitalisation Reliably identifying congestion prior to the development of these signs would facilitate earlier intervention treatment to de-congest and may prevent hospitalisations Patients who do require hospital admission are often discharged with residual congestion which is associated with readmission and increased risk of death Tests that correlate closely with the degree of congestion and track with decongestion could guide therapy and help with decision-making about suitability for hospital discharge
The investigators propose to recruit 140 patients Patients will be identified during hospitalisation with HF or prior to implantation of a cardiac resynchronisation therapy CRT device Each patient will have a history physical examination electrocardiogram ECG echocardiogram cardiac ultrasound and lung ultrasound performed Some patients will have a procedure to record pressure measurements within the heart right heart catheterisation if clinically indicated as routine care Blood and urine tests will also be taken
The aim of this study is to evaluate the accuracy of novel blood and urine tests at measuring congestion compared with standard assessments This may help in the discovery and development of new and improved tests for assessing congestion
HF hospitalisations are frequently preceded by a period of increasing congestion pressure elevation within heart chambers and excess body fluid The identification of congestion can be difficult Current tests have limitations and signs of congestion such as lung crackles or leg swelling that can be recognised by health care professionals are often seen at a late stage before an intervention can be made to prevent hospitalisation Reliably identifying congestion prior to the development of these signs would facilitate earlier intervention treatment to de-congest and may prevent hospitalisations Patients who do require hospital admission are often discharged with residual congestion which is associated with readmission and increased risk of death Tests that correlate closely with the degree of congestion and track with decongestion could guide therapy and help with decision-making about suitability for hospital discharge
The investigators propose to recruit 140 patients Patients will be identified during hospitalisation with HF or prior to implantation of a cardiac resynchronisation therapy CRT device Each patient will have a history physical examination electrocardiogram ECG echocardiogram cardiac ultrasound and lung ultrasound performed Some patients will have a procedure to record pressure measurements within the heart right heart catheterisation if clinically indicated as routine care Blood and urine tests will also be taken
The aim of this study is to evaluate the accuracy of novel blood and urine tests at measuring congestion compared with standard assessments This may help in the discovery and development of new and improved tests for assessing congestion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None