Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH

Pulmonary Artery Hypertension Clinical Trial

— REPEAT-PAH  

Official title:

Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH (REPEAT-PAH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421949
• Other study ID #: STH20981
• Status: Completed
• Start date: February 19, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2023
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 patient's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients who have met the criteria for The Sheffield Teaching Hospitals Observational Study of Patients with Pulmonary Hypertension, Cardiovascular and other Respiratory Diseases (STH-ObS)

• Patient diagnosed with Group 1 PAH, including IPAH, HPAH, PAH-CTD but excluding PAH-CHD. Mean pulmonary artery pressure >20mmHg, PAWP =15mmHg and PVR >240 dynes.

• Willing to participate in the study and able to provide informed consent

Exclusion Criteria:

• Diagnosed with PAH-CHD or any non-group 1 PH

• Creatinine clearance < 15 ml/min/m2

Related Conditions & MeSH terms

• Pulmonary Arterial Hypertension
• Pulmonary Artery Hypertension

Intervention

Other:
• Exercise group
Incremental Shuttle Walking Test

Locations

Country	Name	City	State
United Kingdom	Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Actelion

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The repeatability of laboratory and POCT samples for NT-proBNP and BNP in patients at rest with PAH.	Comparisons will be made between time point 1 (T1) and 2 (T2) in the absence of exercise for venous blood using POCT kits and for venous blood using laboratory analysis, for both BNP and NT-proBNP.	18 months
Primary	The effect of a pre-processing time delay on performance of NT-proBNP test	Comparison will be made between samples sent directly to the laboratory and those that were delayed in being sent by 48 hours. Pre-specified levels will be used to determine the performance of the test as excellent (eg >=0.75), good, fair or poor.	18 months
Primary	The impact of exercise testing using the incremental shuttle walking test (ISWT) on NT-proBNP and BNP on both laboratory and POCT samples	Comparison will be made between venous blood using POCT kits and venous blood using laboratory testing at rest and post exercise, for both BNP and NT-proBNP.	18 months
Primary	The impact of treatment change or escalation on the results of POCT and The change in POCT and laboratory samples for NT-proBNP and BNP.	POCT and laboratory samples for NT-proBNP and BNP will be assessed to see if they detected change in patients who had a change or escalation in treatment.	18 months