Effect of Standard vs Intense Hypertension Management on Nighttime Blood Pressure

标准与强化高血压管理对夜间血压的影响

• 批准号: 8768575
• 负责人: Paul Englund Drawz
• 金额: $ 7.6万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8768575
• 关键词: Address; Adverse event; Affect; Ambulatory Blood Pressure Monitoring; Ancillary Study; Antihypertensive Agents; Blood Pressure; Cardiovascular Diseases; Cardiovascular system; Chronic Kidney Failure; Clinic; Clinical; Clinical Trials; Coupled; Data; Diabetes Mellitus; Disease Progression; Dose; End stage renal failure; Enrollment; Future; Goals; Hypertension; Hypotension; Individual; Intervention Trial; Kidney; Kidney Diseases; Knowledge; Leadership; Measurement; Monitor; Morbidity - disease rate; Negative Finding; Observational Study; Outcome; Parents; Participant; Patients; Pharmaceutical Preparations; Phase; Premature Mortality; Principal Investigator; Proteinuria; Protocols documentation; Reporting; Research; Research Personnel; Risk; Risk Factors; Time; adverse outcome; base; cardiovascular disorder risk; career; cohort; experience; high risk; hypertension treatment; insight; modifiable risk; mortality; primary outcome; public health relevance; randomized trial; secondary outcome

DESCRIPTION (provided by applicant): Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Early hypertension studies showed that treating elevated blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality. In subsequent research, patients achieved greater improvement in cardiovascular outcomes when their treatment was aimed at a moderate systolic BP target (<150mmHg) than at higher targets. Although observational data suggest that even lower BP targets may be beneficial, this has not been seen in randomized trials; instead, "intense" treatment of hypertension (i.e., to a target systolic BP <120mmHg) was found to have no effect on participants' risk for renal disease, cardiovascular disease, or all-cause mortality. One potential explanation for this apparent lack of benefit of intense BP targets is that the study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory BP monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic BP appears to be the best predictor of cardiovascular disease and all-cause mortality. Because recent trials assessing intense BP targets did not include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is largely unknown. To address this important gap in knowledge, we will conduct ABPM in 950 participants as part of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT). The goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of peak BP, 24hr BP, and BP variability (secondary outcomes). Regardless of the outcomes, completion of the proposed ancillary study will significantly impact the direction of future hypertension research. If intensive treatment of BP is associated with lower nighttime BP, then results from the parent SPRINT study will demonstrate the effect (positive or negative) of achieving lower nighttime BP on important cardiovascular and renal outcomes. Alternatively, negative overall SPRINT results coupled with an ancillary study finding of "no difference" in nighttime BP between the groups will indicate the need for future trials to determine whether lowering nighttime BP reduces the risk for CKD progression, end-stage renal disease, and cardiovascular disease. In addition, the proposed study will provide mechanistic insight into the primary SPRINT results by elucidating the effect of intense clinic BP targets on dipping, the timing of peak BP, and BP variability. Lastly, this ancillary study will provide the principal investigator with leadership experience within a large, ongoing clinical trial, thereby preparing the candidate for a career as an independent clinical researcher, with the long- term goal of reducing the morbidity and mortality associated with hypertension through therapies targeted to specific components of ambulatory BP.

描述（由申请人提供）：高血压是心血管和肾脏疾病的主要危险因素，也是全世界过早死亡的主要原因。早期高血压研究表明，治疗高血压（BP）可降低患者患心血管疾病和全因死亡率的风险。在随后的研究中，当患者的治疗目标是中等收缩压目标（<150mmHg）时，与更高目标相比，患者的心血管结局得到了更大的改善。尽管观察数据表明，更低的血压目标可能是有益的，但随机试验尚未发现这一点；相反，“强化”高血压治疗（即目标收缩压<120mmHg）被发现对参与者患肾病、心血管疾病或全因死亡率的风险没有影响。对于严格的血压目标明显缺乏益处的一个可能的解释是，该研究 方案的目标是降低诊所血压而不是动态血压。动态血压监测 (ABPM) 可以全天评估血压。在所有血压测量中，夜间收缩压似乎是心血管疾病和全因死亡率的最佳预测指标。由于最近评估强化血压目标的试验不包括动态血压测量，因此强化治疗对夜间血压的影响很大程度上未知。为了弥补这一重要的知识差距，我们将对 950 名参与者进行 ABPM，作为正在进行的收缩压干预试验 (SPRINT) 的辅助研究的一部分。辅助研究的目的是评估强化与标准的效果 基于夜间血压（主要结果）以及夜间/白天血压比率、峰值血压时间、24 小时血压和血压变异性（次要结果）的临床血压目标。无论结果如何，拟议的辅助研究的完成将显着影响未来高血压研究的方向。如果血压的强化治疗与较低的夜间血压相关，那么母体 SPRINT 研究的结果将证明实现较低的夜间血压对重要的心血管和肾脏结局的影响（积极或消极）。或者，总体 SPRINT 阴性结果加上辅助研究发现各组之间夜间血压“无差异”，将表明需要进行未来的试验来确定降低夜间血压是否可以降低 CKD 进展、终末期肾病和心血管疾病的风险。此外，拟议的研究将通过阐明严格的临床血压目标对血压下降、峰值血压时间和血压变异性的影响，为主要 SPRINT 结果提供机制见解。最后，这项辅助研究将为主要研究者提供在一项大型、正在进行的临床试验中的领导经验，从而使候选人为独立临床研究人员的职业生涯做好准备，其长期目标是通过针对动态血压特定组成部分的治疗来降低与高血压相关的发病率和死亡率。