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: 8898067
• 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/8898067
• 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; Health; Hypertension; Hypotension; Individual; Intervention Trial; Kidney; Kidney Diseases; Knowledge; Leadership; Measurement; Monitor; Morbidity - disease rate; Negative Finding; Observational Study; Outcome; Parents; Participant; Patient risk; Patients; Pharmaceutical Preparations; Phase; Premature Mortality; Principal Investigator; Proteinuria; Protocols documentation; Reporting; Research; Research Personnel; Risk; Risk Factors; Time; adverse outcome; base; blood pressure reduction; career; cohort; experience; high risk; hypertension treatment; insight; modifiable risk; mortality; primary outcome; randomized trial; secondary outcome; targeted treatment

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，也是全球过早死亡率的主要原因。早期高血压研究表明，治疗升高血压（BP）会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，当患者的治疗针对中等的收缩BP靶标（<150mmHg）时，患者的心血管结局得到了更大的改善。尽管观察数据表明，甚至较低的BP目标可能是有益的，但在随机试验中尚未看到。取而代之的是，发现对高血压的“强烈治疗”（即针对目标收缩期BP <120mmHg）对参与者患肾脏疾病，心血管疾病或全因死亡率的风险没有影响。对于这种明显缺乏强烈的BP目标的益处的一种潜在解释是该研究 方案针对诊所BP而非卧床BP的降低。卧床BP监测（ABPM）允许整个白天和黑夜评估BP。在所有BP测量中，夜间收缩BP似乎是心血管疾病和全因死亡率的最佳预测指标。由于最近评估强烈BP目标的试验不包括卧床BP的测量，因此强化治疗对夜间BP的影响在很大程度上是未知的。为了解决知识的这一重要差距，我们将在950名参与者中进行ABPM，这是一项辅助研究的一部分，用于正在进行的收缩压干预试验（SPRINT）。辅助研究的目的是评估密集型与标准的效果 基于诊所的BP目标是夜间BP（主要结果）以及夜间/白天比率，峰值BP的时间，24小时BP和BP变异性（次要结果）。无论结果如何，拟议的辅助研究的完成将显着影响未来的高血压研究的方向。如果BP的密集治疗与较低的夜间BP有关，则父型Sprint研究的结果将证明降低夜间BP对重要心血管和肾脏结局的影响（正或负）。或者，负面的整体冲刺结果以及辅助研究发现两组之间夜间BP的“无差异”的辅助研究将表明需要进行以后的试验，以确定降低夜间BP是否会降低CKD进展，终末期肾脏疾病和心血管疾病的风险。此外，拟议的研究将通过阐明强烈的诊所BP目标对浸入，峰值BP的时间和BP变异性的影响来提供对主要冲刺结果的机理见解。最后，这项辅助研究将为首席研究人员提供一项大型临床试验的领导经验，从而为候选人做好了作为独立临床研究人员的职业准备，其长期目标是通过降低针对Ambulatory BP的特定成分的疗法来降低与高血压相关的发病率和死亡率。