Home Blood Pressure in Hemodialysis (HOME-BP)

血液透析中的家庭血压 (HOME-BP)

• 批准号: 10847268
• 负责人: Nisha Bansal
• 金额: $ 40.55万
• 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/10847268
• 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.

项目摘要 血压升高（BP）是心血管疾病最重要的、潜在可改变的危险因素之一， 疾病（CVD）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，由于相互冲突的关联，该人群的BP管理仍然不确定 取决于BP测量的设置。我们和其他人报道了一个矛盾的U形关联 透析前收缩压（SBP）伴CVD事件和死亡，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，透析单位外SBP与死亡风险之间的相关性 CVD是线性的。我们假设目标是透析外单位（如家庭）SBP，而不是透析前SBP SBP（目前的做法）将导致不同的治疗措施和更好的结果。这将是一个 由于指南不推荐以家庭BP为目标，大多数临床医生也不实践，因此范式转变。 为了测试血液透析患者家庭血压测量和治疗的可行性，我们完成了一项为期4个月的试点研究 在2家中心随机分配接受家庭SBP与术前SBP治疗的50例HD患者的临床试验（NCT 03459807） 透析SBP目标<140 mmHg。这项试点试验证实，我们的战略，以衡量和治疗家庭 HD患者的SBP是可行的（具有良好的复张/保留和对家庭BP的依从性 测量;以及成功采用标准化治疗算法）。我们还发现了几个 患者水平的家庭血压测量依从性促进者，包括：每周家庭血压测量 日程安排;短信提醒;以及使用自动BP传输技术。从这些数据来看， 我们假设，目前阻碍家庭BP应用于实践的障碍包括：（1）缺乏关于 家庭BP治疗对重要中间结果的影响;（2）缺乏来自其他中心的数据， 美国显示普遍性（因为大多数美国文献来自单一中心）;（3）缺乏纵向 关于目标透析前BP对家庭BP影响的数据（反之亦然，部分原因是为了表明家庭BP 无法从透析单元BP预测）;（4）缺乏对采用医生级障碍的了解 治疗HD患者的家庭BP;（5）缺乏使用现代技术的长期依从性数据， 支持临床应用。 为了解决这些差距，我们现在提出了一个更大的（N=200）双中心交叉随机临床试验， HD患者家庭SBP目标与透析前SBP目标（<140 mmHg）的更长随访期（12个月） 患者这项研究产生的数据将为接下来的几个步骤奠定基础，包括一个更大的， 一项多中心试验，旨在测试使用不同家庭BP目标的治疗，以降低HD患者的CVD发生率和死亡率 患者以及实施科学试验，将家庭血压测量纳入临床护理。