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CompletedNCT05421949REPEAT-PAHUpdated Aug 14, 2023

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

An observational study in Pulmonary Artery Hypertension, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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 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.
02

Conditions studied

  • Pulmonary Artery Hypertension
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 207 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with pulmonary arterial hypertension

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

Exclusion Criteria:

  • Diagnosed with PAH-CHD or any non-group 1 PH
  • Creatinine clearance \< 15 ml/min/m2
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherExercise group

    Incremental Shuttle Walking Test

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

  2. 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.

    Time frame: 18 months

  3. 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.

    Time frame: 18 months

  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.

    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.

    Time frame: 18 months

07

Study locations

1 site
  • Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital
    Sheffield, South Yorkshire S10 2JF, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05421949
Lead sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Actelion
Responsible party
Sponsor
First posted
Jun 16, 2022
Start date
Feb 19, 2021
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022
Last update
Aug 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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