Home Blood Pressure in Hemodialysis (HOME-BP)

血液透析中的家庭血压 (HOME-BP)

• 批准号: 10643813
• 负责人: Nisha Bansal
• 金额: $ 68.1万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10643813
• 关键词: Address; Adherence; Adopted; Adoption; Algorithms; Attitude; Belief; Blood Pressure; Cardiovascular Diseases; Cessation of life; Clinical; Clinical Trials; Cross-Over Studies; Data; Dialysis procedure; Dryness; Event; Fatigue; Foundations; Goals; Guidelines; Health Technology; Hemodialysis; Heterogeneity; Home; Hypotension; Knowledge; Literature; Maintenance; Measurement; Measures; Modernization; Multicenter Trials; Muscle Cramp; Outcome; Participant; Patients; Perception; Phase; Physicians; Pilot Projects; Population; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Research Design; Risk Factors; Schedule; Shapes; Standardization; Surveys; Technology; Testing; Text Messaging; Time; Titrations; Weight; adverse outcome; blood pressure control; blood pressure elevation; blood pressure medication; cardiovascular risk factor; clinical care; design; feasibility testing; follow-up; high risk; implementation science; improved; mHealth; modifiable risk; mortality; mortality risk; optimal treatments; pilot trial; post intervention; primary outcome; randomized, clinical trials; recruit; secondary outcome; transmission process; treatment arm; treatment effect; treatment strategy; willingness

PROJECT SUMMARY Elevated blood pressure (BP) is one of the most important, potentially modifiable risk factors for cardiovascular disease (CVD) events and death. Hemodialysis (HD) patients are at particularly high risk for these adverse outcomes. Yet the management of BP in this population remains uncertain due to conflicting associations depending on setting of BP measurement. We and others have reported a paradoxical, U-shaped association of pre-dialysis systolic BP (SBP) with CVD events and death, where the nadir of the U-shape is 140-160 mmHg. However, in these same patients, the association between out-of-dialysis unit SBP and risk of mortality and CVD is linear. We hypothesize that targeting out-of-dialysis unit (e.g. home) SBP rather than pre-dialysis SBP (the current practice) will lead to different treatment actions and better outcomes. This would be a paradigm shift since targeting home BP is not recommended by guidelines nor is practiced by most clinicians. To test feasibility of home BP measurement and treatment in HD patients, we completed a 4-month pilot clinical trial (NCT03459807) of 50 HD patients at 2 centers randomized to treatment of home SBP vs. pre- dialysis SBP target of <140 mmHg. This pilot trial confirmed that our strategy to measure and treat home SBP in HD patients was feasible (with excellent recruitment/retention and adherence to home BP measurement; and successful adoption of a standardized treatment algorithm). We also identified several patient-level facilitators of adherence to home BP measurement including: weekly home BP measurement schedule; text message reminders; and use of technology for automated BP transmission. From these data, we hypothesize that ongoing barriers to adoption of home BP into practice include: (1) lack of data on the effect of treatment of home BP on important intermediate outcomes; (2) lack of data from other centers in the U.S. to show generalizability (as most of the U.S. literature is from a single center); (3) lack of longitudinal data on the effect of targeting pre-dialysis BP on home BP (and vice versa, in part to show that home BP cannot be predicted from dialysis unit BP); (4) lack of knowledge of physician-level barriers to adopt treatment of home BP in HD patients; and (5) lack of long-term adherence data using modern technology to support clinical adoption. To address these gaps, we now propose a larger (N=200) two-center cross-over randomized clinical trial with longer follow-up (12 month) targeting a home SBP goal vs. a pre-dialysis SBP goal of <140 mmHg in HD patients. The data generated from this study will lay the foundation for several next steps, including a larger, multi-center trial to test treatment using different home BP targets to reduce rates of CVD and mortality in HD patients as well as an implementation science trial to integrate home BP measurement into clinical care.

项目概要 血压升高 (BP) 是心血管疾病最重要且可能可改变的危险因素之一 疾病（CVD）事件和死亡。血液透析 (HD) 患者发生这些不良反应的风险特别高 结果。然而，由于相互矛盾的关联，该人群的血压管理仍不确定 取决于血压测量的设置。我们和其他人报告了一种矛盾的 U 形关联 透析前收缩压 (SBP) 与 CVD 事件和死亡的关系，其中 U 形的最低点为 140-160 毫米汞柱。然而，在这些相同的患者中，透析外 SBP 与死亡风险之间的关联 CVD 是线性的。我们假设针对透析外（例如家庭）SBP 而不是透析前 SBP（目前的做法）将带来不同的治疗行动和更好的结果。这将是一个 范式转变，因为指南不推荐以家庭血压为目标，大多数临床医生也没有实践。 为了测试 HD 患者家庭血压测量和治疗的可行性，我们完成了为期 4 个月的试点 临床试验 (NCT03459807)，对 2 个中心的 50 名 HD 患者进行随机分配，接受家庭 SBP 治疗与预治疗 透析收缩压目标<140 mmHg。这项试点试验证实了我们测量和治疗家庭的策略 HD 患者的 SBP 是可行的（具有出色的恢复/保留和遵守家庭血压 测量;并成功采用标准化治疗算法）。我们还确定了几个 患者层面坚持家庭血压测量的促进因素包括： 每周家庭血压测量 日程;短信提醒；以及使用自动血压传输技术。从这些数据来看， 我们假设将家庭血压应用于实践的持续障碍包括：(1) 缺乏关于家庭血压的数据 家庭血压治疗对重要中间结果的影响； (2) 缺乏来自其他中心的数据 美国表现出普遍性（因为大多数美国文献都来自一个中心）； (3)缺乏纵向 关于目标透析前血压对家庭血压影响的数据（反之亦然，部分是为了表明家庭血压 无法从透析装置 BP 预测）； (4)缺乏对医师级采用障碍的认识 HD 患者的家庭血压治疗； (5)缺乏使用现代技术的长期依从性数据 支持临床采用。 为了解决这些差距，我们现在提出一项更大规模（N=200）的两中心交叉随机临床试验，其中 HD 患者的家庭 SBP 目标与透析前 SBP 目标 <140 mmHg 相比，进行了更长的随访（12 个月） 患者。这项研究产生的数据将为后续几个步骤奠定基础，包括更大规模的、 多中心试验，测试使用不同家庭血压目标的治疗方法，以降低 HD 的 CVD 发生率和死亡率 患者以及将家庭血压测量纳入临床护理的实施科学试验。