Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH (REPEAT-PAH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The repeatability of laboratory and POCT samples for NT-proBNP and BNP in patients at rest with PAH.
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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
排除标准
- Diagnosed with PAH-CHD or any non-group 1 PH
- Creatinine clearance < 15 ml/min/m2
结局指标
主要结局
The repeatability of laboratory and POCT samples for NT-proBNP and BNP in patients at rest with PAH.
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05421949
- 其他研究编号
- STH20981
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (4年前)
- 研究完成日期
- (4年前)
- 最近核实
- 最近更新
- (3年前)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否