Pulmonary Artery HypertensionREPEAT-PAHNCT05421949
Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH
An observational study of Pulmonary Artery Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pulmonary Artery Hypertension
- What is being tested?
- Exercise group
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2021to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pulmonary arterial hypertension
Who may be able to join
- 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
Who cannot join
- Diagnosed with PAH-CHD or any non-group 1 PH
- Creatinine clearance < 15 ml/min/m2
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH (REPEAT-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.
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.
- Conditions
- Pulmonary Artery Hypertension
- Being tested
- Exercise group
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupOther
Incremental Shuttle Walking Test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start19 Feb 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421949
- Sponsor's protocol ID
- STH20981
- Acronym
- REPEAT-PAH
- Status last verified
- Aug 2023
- First submitted
- 7 Jun 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40611611
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH (REPEAT-PAH)
- ClinicalTrials.gov ID
- NCT05421949
- Acronym / sponsor ID
- REPEAT-PAH / STH20981
- Conditions
- Pulmonary Artery Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | – | Other: Exercise groupPatients who have been randomised to the exercise group will be asked to undertake a incremental shuttle walking test following their initial blood tests. |
| No Exercise | – | –Patients who have been randomised to the exercise group will be asked to rest for 60 minutes following their initial blood tests. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pulmonary arterial hypertension
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with PAH-CHD or any non-group 1 PH
- Creatinine clearance < 15 ml/min/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise groupIncremental Shuttle Walking Test | Other | Exercise |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 40611611Durrington 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Artery Hypertension, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The repeatability of laboratory and POCT samples for NT-proBNP and BNP in patients at rest with PAH. (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05421949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.