Clinical trial NCT05421949: Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH
Official title: Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH (REPEAT-PAH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Artery Hypertension
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2022-06-16
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary arterial hypertension

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The repeatability of laboratory and POCT samples for NT-proBNP and BNP in patients at rest with PAH.
timeFrame: 18 months
measure: The effect of a pre-processing time delay on performance of NT-proBNP test
timeFrame: 18 months
measure: The impact of exercise testing using the incremental shuttle walking test (ISWT) on NT-proBNP and BNP on both laboratory and POCT samples
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
References: