A pilot study to target out-of-dialysis-unit versus dialysis-unit blood pressure

针对透析单位外血压与透析单位血压的初步研究

• 批准号: 9370801
• 负责人: Nisha Bansal
• 金额: $ 25.5万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-02 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9370801
• 关键词: Adherence; Algorithms; Ambulatory Blood Pressure Monitoring; Antihypertensive Agents; Blood Pressure; Blood Pressure Monitors; Cardiac; Cardiovascular Diseases; Cessation of life; Clinical; Clinical Trials; Data; Dialysis patients; Dialysis procedure; Dizziness; Effectiveness; End stage renal failure; Enrollment; Epidemiology; Event; Fatigue; General Population; Goals; Guidelines; Hemodialysis; Home Blood Pressure Monitoring; Home environment; Hour; Hypertension; Hypotension; Intervention; Intervention Studies; Lead; Logistics; Maintenance; Measurement; Measures; Multi-Institutional Clinical Trial; Multicenter Studies; Muscle Cramp; Myocardial Stunning; Organ; Outcome; Participant; Patients; Pattern; Pharmaceutical Preparations; Physicians; Pilot Projects; Population; Provider; Randomized; Randomized Controlled Trials; Reading; Recovery; Recruitment Activity; Reporting; Risk; Risk Factors; Safety; Subgroup; Technology; Testing; Time; Titrations; Training; Uncertainty; United States National Institutes of Health; Weight; adverse outcome; arm; base; blood pressure regulation; cardiovascular disorder risk; cardiovascular risk factor; cohort; data exchange; design; field study; high risk; improved; mHealth; modifiable risk; mortality; novel; pilot trial; reduce symptoms; research study; safety and feasibility; safety testing

PROJECT SUMMARY Our long-term goal is to change the paradigm of blood pressure (BP) management in maintenance hemodialysis (HD) patients to improve clinical outcomes. Our hypothesis is that risk cardiovascular disease (CVD) events and mortality will be lowered in HD patients if physicians measure and treat out-of-dialysis-unit BP, rather than dialysis-unit BP, which is the current practice and what guidelines recommend. This hypothesis is based on novel observation data from our group and others. We recently showed in a multi-center cohort of incident HD patients that while there was a “paradoxical” U- shaped association between dialysis-unit systolic BP (SBP) and risk of all-cause mortality and CVD events, there was a linear stepwise association between SBP measured outside of the dialysis-unit and risk of mortality and CVD events, in a pattern similar to that in the general population. Since there is poor correlation between dialysis-unit and out-of-dialysis-unit SBP, targeting dialysis-unit SBP may lead to overtreatment in a substantial number of patients (those with high dialysis-unit but low out-of-dialysis-unit SBP). This may cause intra-dialytic hypotension, myocardial stunning and adverse cardiac remodeling. Concurrently, other patients may be undertreated (those with low dialysis-unit SBP but high out-of-dialysis-unit SBP), which may result in end-organ damage. In this application, we propose to conduct a two-center pilot clinical trial to test the feasibility and safety of targeting an out-of-dialysis-unit (home) SBP goal of <140 mmHg vs. a dialysis-unit (pre-dialysis) SBP goal of <140 mmHg among 50 prevalent HD patients using an algorithm of dry weight and BP medication adjustment. To facilitate a pragmatic and clinically feasible approach to out-of-dialysis-unit/home BP readings, we will test a validated mobile health BP monitor capable of Bluetooth enabled data transmission. The specific aims are: 1) to determine the feasibility of and adherence to a strategy of dry weight adjustment and anti- hypertensive medication titration to achieve an out-of-dialysis-unit (home) SBP <140 mmHg vs. a dialysis-unit (pre- dialysis) SBP <140 mmHg over 6 months and 2) to test the safety and tolerability of an intervention to achieve out-of- dialysis-unit (home) systolic blood pressure <140 mmHg. This pilot trial will be a key intermediate step to help design a large, multi-center clinical trial to test whether targeting out-of-dialysis-unit (home) SBP vs. dialysis-unit (pre-dialysis) SBP among maintenance HD patients will reduce rates of CVD events and mortality in maintenance HD patients. Data from this study will be to test study logistics, optimize the study intervention, identify barriers and facilitators of implementation and obtain empirical estimates of study parameters to help design the definitive clinical trial.

项目摘要 我们的长期目标是改变维持性血液透析（HD）中血压（BP）管理的范式 患者改善临床效果。我们的假设是，心血管疾病（CVD）事件的风险和死亡率将 如果医生测量和治疗透析单元外血压，而不是透析单元血压， 目前的做法和指导方针的建议。这一假设是基于我们小组的新观察数据 等人我们最近在一个多中心的HD患者队列中发现，虽然存在一个“矛盾的”U型， 透析单位收缩压（SBP）与全因死亡率和CVD事件风险之间的相关性， 透析室外测量的SBP与死亡率和CVD事件风险之间的线性逐步相关性， 与一般人群相似。 由于透析机和透析机外收缩压之间的相关性较差，因此针对透析机收缩压可能会导致 大量患者过度治疗（透析单位高但透析单位外SBP低）。这 可能导致透析中低血压、心肌顿抑和不良心脏重塑。同时，其他患者 可能治疗不足（透析单位SBP低但透析单位外SBP高），这可能导致终末器官 损害 在这项申请中，我们建议进行一项双中心试点临床试验，以测试靶向治疗的可行性和安全性。 透析室外（家庭）SBP目标<140 mmHg与透析室（透析前）SBP目标<140 mmHg， 使用干体重和BP药物调整算法的普遍HD患者。为了促进一个务实和 临床上可行的透析单元外/家庭BP读数方法，我们将测试经确认的移动的健康BP监测仪 能够进行蓝牙数据传输。 具体目的是：1）确定干重调整和抗- 高血压药物滴定，以实现透析单元外（家庭）SBP <140 mmHg，而透析单元（术前） 透析）6个月内SBP <140 mmHg和2）测试干预的安全性和耐受性，以实现 透析单位（家庭）收缩压<140 mmHg。 这项试点试验将是一个关键的中间步骤，以帮助设计一个大型的，多中心的临床试验，以测试是否靶向 维持性HD患者的透析室外（家庭）SBP与透析室（透析前）SBP相比， 维持性HD患者的CVD事件和死亡率。本研究的数据将用于测试研究后勤，优化 研究干预，确定实施的障碍和促进因素，并获得研究参数的经验估计 来帮助设计最终的临床试验