BiOmarkers in Urine, anTihypeRtensive trEAtment and Blood Pressure Control in Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 21
- 主要终点
- Change in Clinic systolic blood pressure
研究概览
简要总结
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence. Our project will assess whether high performance liquid chromatography mass spectrometry (HPLC-MS/MS)-guided intervention (providing patients with information on the results of their HPLC-MS/MS-based urine analysis combined with targeting the main reason for non-adherence) leads to an improvement in blood pressure control, adherence and a reduction in healthcare costs. Our multicentre prospective randomised controlled trial consists of 6 stages (screening, recruitment, baseline phenotype assessment, intervention, short-term and long-term outcome visits). The study will fill in an important gap in knowledge on management of blood pressure in non-adherent hypertensive patients beyond the initial diagnostic step. It will also inform the development of a cost-effective model for the management of non-adherence in chronic disorders that require long-term drug therapy.
详细描述
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence.
An ultra-sensitive and highly specific biochemical assay has been developed to detect urinary biomarkers of antihypertensive treatment. The high performance liquid chromatography mass spectrometry (HPLC-MS/MS)-based assay screens spot urine samples for the presence of 40 commonly prescribed blood pressure lowering medications. The results of the test provide a clinician with information on the presence/absence of prescribed antihypertensive drugs or/and their metabolites in urine - a direct confirmation of therapeutic adherence/non-adherence.
The study is a prospective multi-centre randomised controlled trial to examine if HPLC-MS/MS-guided intervention is superior to standard clinical care in improving clinical, behavioural and health-economy outcomes in hypertensive patients who are non-adherent to antihypertensive treatment.
Patient adherence to antihypertensive treatment will be determined at baseline. Non-adherent hypertensive patients at baseline will be randomised in a 1:1 ration to either usual clinical care plus HPLC-MS/MS-guided intervention (Arm A) or usual clinical care only (Arm B).
The study also evaluates a cohort of patients who are adherent to antihypertensive treatment at baseline. Those adherent hypertensive patients will receive the usual clinical care (Arm C). The main purpose of involving this group of patients is to blind the clinical research staff to the adherence status of those patients randomised receiving standard care alone, to prevent introducing any bias in treating non-adherent patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and clinicians will initially be blinded to the result of the baseline (at trial entry) HPLC-MS/MS based urine test to determine the participant adherence to antihypertensive treatment.
Non-adherent patients allocated to Arm A will be un-blinded at the stage of visit 3 where the results of their HPLC-MS/MS urine test will be revealed to them as a part of HPLC-MS/MS-guided intervention. The doctor will also require un-blinding to provide the required intervention. However, during further study visits the research personnel will remain blinded as to the adherence status of these patients, the results of their HPLC-MS/MS-based analysis and the treatment allocation. The doctor who delivers the intervention will not be involved in collecting clinical information necessary to define outcomes during appointments 4 and 5.
Hypertensive patients randomised to Arms B and C will remain blinded to the results of their HPLC-MS/MS-based urine test throughout all stages of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or above
- •Patients previously diagnosed with and pharmacologically managed for hypertension
- •Patients with antihypertensive treatment with at least two antihypertensive medications
- •Patients have full capability of providing informed consent
排除标准
- •Patients with recent history of admission to the hospital relating to their hypertension or treatment with anti-hypertensive medications (<2 weeks) (i)
- •Patient refusal for 7-day home-based blood pressure monitoring (7-HBBPM)
- •Self-reported pregnancy or breastfeeding
- •Female patients planning to conceive within the next 6 months
- •(i) Including admission to A&E
结局指标
主要结局
Change in Clinic systolic blood pressure
时间窗: visit 4 (short term follow-up; approx. 3 months post intervention, when feasible to conduct)
Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
次要结局
- Change in urinary albumin / creatinine ratio(visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct))
- Change in clinic diastolic blood pressure(visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct))
- Change in biochemical adherence of patients(visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct))
- Change in clinic systolic blood pressure(visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct))
- Changes in health economy parameters(visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct))
- Change in home blood pressure(visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct))
研究者
Maciej Tomaszewski
Professor of Cardiovascular Medicine
University of Manchester