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(申请人提供)：高血压是心血管和肾脏疾病的主要危险因素，也是全球过早死亡的主要原因。早期的高血压研究表明，治疗高血压(BP)可以降低患者患心血管疾病的风险和全因死亡率。在随后的研究中，当患者的治疗目标是中等收缩压目标(&lt；150 mmHg)时，患者在心血管结果方面取得了比更高目标更大的改善。尽管观察数据表明，更低的血压目标可能是有益的，但在随机试验中还没有看到这一点；相反，研究发现，高血压的“高强度”治疗(即达到目标收缩压120毫米汞柱)对参与者患肾脏疾病、心血管疾病或全因死亡的风险没有影响。对这种明显缺乏密集BP目标好处的潜在解释是，这项研究 方案的目标是降低临床血压，而不是动态血压。动态血压监测(ABPM)允许全天候评估血压。在所有的血压测量中，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。由于最近评估高强度血压目标的试验不包括动态血压测量，强化治疗对夜间血压的影响在很大程度上是未知的。为了解决这一重要的知识差距，我们将在950名参与者中进行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。辅助研究的目标是评估强化与标准的效果。 以临床为基础的血压目标是夜间血压(主要结果)，以及夜间/白天血压比率、血压峰值时间、24小时血压和血压变异性(次要结果)。无论结果如何，拟议的辅助研究的完成将对未来高血压研究的方向产生重大影响。如果强化治疗血压与降低夜间血压有关，那么Parent Sprint研究的结果将证明夜间血压降低对重要的心血管和肾脏结果的影响(积极或消极)。或者，Sprint的总体结果为负，再加上一项辅助研究发现两组患者夜间血压“无差异”，这表明有必要进行进一步的试验，以确定降低夜间血压是否能降低慢性肾脏病进展、终末期肾病和心血管疾病的风险。此外，这项拟议的研究将通过阐明临床高强度血压目标对血压下降的影响、血压峰值的时间和血压变异性，提供对初步冲刺结果的机械性洞察。最后，这项辅助研究将为首席研究人员提供正在进行的大型临床试验中的领导经验，从而为候选人成为一名独立的临床研究人员做好准备，其长期目标是通过针对动态血压的特定成分的治疗来降低与高血压相关的发病率和死亡率。