Home Blood Pressure in Hemodialysis (HOME-BP)

血液透析中的家庭血压 (HOME-BP)

• 批准号: 10395924
• 负责人: Nisha Bansal
• 金额: $ 72.83万
• 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/10395924
• 关键词: Address; Adherence; Adopted; Adoption; Aftercare; Algorithms; Attitude; Belief; Blood Pressure; Cardiovascular Diseases; Cessation of life; Clinical; Clinical Trials; Conflict (Psychology); Cross-Over Studies; Data; Dialysis procedure; 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 Clinical Trials; Randomized Controlled Trials; Reading; 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; 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.

项目总结 高血压(BP)是心血管疾病最重要的潜在危险因素之一 疾病(CVD)事件和死亡。血液透析(HD)患者患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，在这一人群中对BP的管理仍然不确定 取决于BP测量的设置。我们和其他人报告了一个自相矛盾的U型关联 透析前收缩压(SBP)与心血管事件和死亡的关系，其中U形的最低点为140-160 毫米汞柱。然而，在这些患者中，脱离透析单元SBP与死亡风险之间的关联 而心血管疾病是线性的。我们假设以透析外单元(如家庭)SBP为目标，而不是透析前 SBP(目前的做法)将导致不同的治疗行动和更好的结果。这将是一个 范式转换，因为指南不推荐以家庭为目标的BP，大多数临床医生也没有这样做。 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 对两个中心的50名HD患者进行的临床试验(NCT03459807)，这些患者随机接受家庭SBP治疗和治疗前的SBP治疗 透析SBP目标为&lt；140毫米汞柱。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(具有良好的招募/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)。我们还确定了几个 患者层面坚持家庭血压测量的促进者，包括：每周家庭血压测量 时间表；短信提醒；以及BP自动传输技术的使用。从这些数据来看， 我们假设，家庭BP进入实践的持续障碍包括：(1)缺乏关于 家族性BP治疗对重要中间结局的影响；(2)缺乏来自中国其他中心的数据。 美国表现出概括性(因为大多数美国文学都来自一个中心)；(3)缺乏纵向 靶向透析前血压对家庭血压影响的数据(反之亦然，部分地表明家庭血压 不能从透析单元(BP)预测；(4)缺乏医生层面的采用障碍知识 HD患者的家庭BP治疗；以及(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的(N=200)双中心交叉随机临床试验， 更长时间的随访(12个月)，目标是家庭SBP目标，而不是透析前&lt；140 mmHg的HD SBP目标 病人。这项研究产生的数据将为下一步的几个步骤奠定基础，包括更大的 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患者的心血管疾病发生率和死亡率 此外，还进行了一项实施科学试验，将家庭血压测量整合到临床护理中。