Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05421949
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-06-07
Brief Title:
Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH REPEAT-PAH
Status:
COMPLETED
Status Verified Date:
2023-08
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:
REPEAT-PAH
Brief Summary:
The purpose of this study is to examine N-terminal pro brain natriuretic peptide NT-proBNP and brain natriuretic peptide BNP biomarkers in a number of different settings including assessing the repeatability of laboratory and point of care testing POCT the effect of a time delay and exercise have on laboratory measurements Also to compare the clinical and analytical performances of NT-proBNP and BNP POCT samples across the spectrum of disease severity and finally assess whether POCT in PAH can detect change in patients commencing or escalating PAH treatment
Detailed Description:
Patients that are attending clinical appointments will be approached to ask if they will take part in the study
Patients will be assessed at two separate visits
Patients will be randomised to either exercise or rest group on their 1st visit On the 2nd visit patients will be asked to participate in the alternate group to what they completed on their previous visit
At each visit they will have 2 blood samples taken at time point 1 and at time point 2 T1 and T2 These will be taken at least one hour apart each with a period of at least 15 mins rest in the sitting position prior to sampling
On one of these two visits the patient will undergo exercise testing between T1 and T2
In addition a further laboratory testing tube will be taken for a delayed NT-proBNP This will be subjected to gentle agitation laboratory rotator for 48 hours prior to processing to simulate in a controlled environment the effect of transport and delay on sample measurement
Retrospectively information will be collected regarding the patients disease severity and any change to treatment that occurred between the two visits
A total of 40 patients with be sampled with an interim analysis after 20 patients
Patients will be assessed at two separate visits
Patients will be randomised to either exercise or rest group on their 1st visit On the 2nd visit patients will be asked to participate in the alternate group to what they completed on their previous visit
At each visit they will have 2 blood samples taken at time point 1 and at time point 2 T1 and T2 These will be taken at least one hour apart each with a period of at least 15 mins rest in the sitting position prior to sampling
On one of these two visits the patient will undergo exercise testing between T1 and T2
In addition a further laboratory testing tube will be taken for a delayed NT-proBNP This will be subjected to gentle agitation laboratory rotator for 48 hours prior to processing to simulate in a controlled environment the effect of transport and delay on sample measurement
Retrospectively information will be collected regarding the patients disease severity and any change to treatment that occurred between the two visits
A total of 40 patients with be sampled with an interim analysis after 20 patients
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