Sharman James E, Stanton Tony, Reid Christopher M, Keech Anthony, Roberts-Thomson Philip, Stewart Simon, Greenough Robert, Stowasser Michael, Abhayaratna Walter P
Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.
Sunshine Coast University Hospital, Birtinya, Australia; School of Medicine, University of Queensland, Brisbane, Australia.
Contemp Clin Trials. 2017 Nov;62:37-42. doi: 10.1016/j.cct.2017.08.010. Epub 2017 Aug 16.
High blood pressure (BP) is the most common modifiable cause of death from cardiovascular disease. Lowering BP with medication improves patient outcomes, but even in populations with normal upper arm (brachial) BP there remains considerable residual risk for cardiovascular disease and this may be due to persistently elevated central BP. There has never been a trial to determine the value of targeted central BP lowering among patients with hypertension, and this was the aim of this study.
This is a multi-centre, randomized, open-label, blinded endpoint trial among 308 patients treated for uncomplicated hypertension with controlled brachial BP (<140/90mmHg) but elevated central BP (≥0.5SD above age- and sex-specific normal values). Baseline recruitment has been completed. Participants were randomized to intervention with spironolactone (25mg/d) or usual care and are being followed over 24months, with the primary outcome being left ventricular mass index (using cardiac magnetic resonance imaging). Brachial and central BP will be measured in the clinic, at home over 7-days and by 24-h ambulatory monitoring. Aortic stiffness will be assessed by carotid-to-femoral pulse wave velocity. Primary (intention to treat) analysis will determine the role of central versus brachial BP for predicting changes in left ventricular mass index.
Compared with control, intervention is expected to significantly lower left ventricular mass index, and this effect is expected to be independently correlated with central BP lowering. These findings would support the concept of central BP as an important therapeutic target in hypertension management. Results are expected in 2018.
高血压是心血管疾病死亡最常见的可改变病因。通过药物降低血压可改善患者预后，但即使在上臂（肱动脉）血压正常的人群中，心血管疾病仍存在相当大的残余风险，这可能是由于中心血压持续升高所致。此前从未有试验确定在高血压患者中降低中心血压的价值，而这正是本研究的目的。
这是一项多中心、随机、开放标签、盲终点试验，研究对象为308例单纯性高血压患者，其肱动脉血压得到控制（<140/90mmHg）但中心血压升高（高于年龄和性别特异性正常值≥0.5标准差）。基线招募已完成。参与者被随机分为接受螺内酯干预（25mg/d）或常规治疗，并进行24个月的随访，主要结局为左心室质量指数（采用心脏磁共振成像）。将在诊所、在家中进行7天测量以及通过24小时动态监测来测量肱动脉血压和中心血压。将通过颈股脉搏波速度评估主动脉僵硬度。主要（意向性治疗）分析将确定中心血压与肱动脉血压在预测左心室质量指数变化方面的作用。
与对照组相比，预计干预可显著降低左心室质量指数，且这一效应预计与中心血压降低独立相关。这些发现将支持中心血压作为高血压管理重要治疗靶点的概念。预计2018年得出结果。
