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

NCT05421949 | Completed

• 1 other identifier: STH20981
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Artery Hypertension

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Exercise

Patients who have been randomised to the exercise group will be asked to undertake a incremental shuttle walking test following their initial blood tests.

Other: Exercise group

No Exercise

Patients who have been randomised to the exercise group will be asked to rest for 60 minutes following their initial blood tests.

Interventions

Exercise group OTHER

Incremental Shuttle Walking Test

Exercise

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary arterial hypertension

You may qualify if:

• 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

You may not qualify if:

• Diagnosed with PAH-CHD or any non-group 1 PH
• Creatinine clearance \< 15 ml/min/m2

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Actelion: collaborator

Study Sites (1)

Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (1)

• Durrington C, Battersby C, Holt L, Fairman A, Strickland S, Salisbury T, Turton HA, Watson L, Smith I, Roman S, Ablott J, Hitchcock F, Roddis C, Oakes E, Wilshaw H, Woodrow I, Armstrong I, Charalampopoulos A, Elliot CA, Hameed A, Hamilton N, Hurdman JA, Lawrie A, Middleton JT, Zafar H, Rothman AMK, Condliffe R, Lewis RA, Kiely DG, Thompson AAR. NT-proBNP and BNP Testing in Pulmonary Arterial Hypertension: Point-of-Care and Remote Monitoring. Respirology. 2025 Nov;30(11):1094-1103. doi: 10.1111/resp.70087. Epub 2025 Jul 3.

  PMID: 40611611 DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 16, 2022
• Study Start: February 19, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

GB (1)