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Completed

NCT Number: NCT05421949

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

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.

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Key information

Conditions

Pulmonary Artery Hypertension Familial Primary Pulmonary Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise group

Other

Incremental Shuttle Walking Test

Primary outcomes

  1. The repeatability of laboratory and POCT samples for NT-proBNP and BNP in patients at rest with PAH.

    Time frame: 18 months

    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.

  2. The effect of a pre-processing time delay on performance of NT-proBNP test

    Time frame: 18 months

    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.

  3. The impact of exercise testing using the incremental shuttle walking test (ISWT) on NT-proBNP and BNP on both laboratory and POCT samples

    Time frame: 18 months

    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.

  4. 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.

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Actelion

Registry information

Official study title

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

Acronym: REPEAT-PAH

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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