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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05421949
Other study ID # STH20981
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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