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）是心血管的最重要，可能改变的危险因素之一 疾病（CVD）事件和死亡。血液透析（HD）患者对这些不良的风险特别高 结果。然而，由于矛盾的关联，该人群中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悖论性的U形关联 带有CVD事件和死亡的透析前收缩BP（SBP）的图，U形的Nadir为140-160 mmhg。但是，在这些同一患者中，非透析单位SBP与死亡风险之间的关联 CVD是线性的。我们假设针对非透析单元（例如家庭）SBP而不是靶标 SBP（当前的实践）将导致不同的治疗措施和更好的结果。这将是一个 大多数临床医生也不建议使用指南，范式不建议针对家庭BP。 为了测试HD患者的家庭BP测量和治疗的可行性，我们完成了4个月的飞行员 在2个中心的50位HD患者的临床试验（NCT03459807）随机治疗家庭SBP与Pre-Pre-pre-pre-pre 透析SBP目标<140 mmHg。这项试验审判证实了我们测量和治疗房屋的策略 高清患者的SBP是可行的（具有出色的招募/保留率和遵守家庭BP 测量;并成功采用了标准化治疗算法）。我们还确定了几个 患者级别遵守家庭BP测量的促进者包括：每周家庭BP测量 日程;短信提醒；并将技术用于自动化BP传输。从这些数据， 我们假设，采用家庭BP的持续障碍包括：（1）缺乏有关的数据 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 美国表现出普遍性（因为美国大多数文献来自一个中心）； （3）缺乏纵向 有关靶向diAysis bp对家庭BP的影响的数据（反之亦然，部分是为了表明家庭BP 不能从透析单位BP预测）； （4）缺乏对医师级障碍的了解 高清患者的家庭BP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，我们现在提出了一个较大（n = 200）两中心的跨界随机临床试验 较长的随访（12个月）针对主场SBP目标，而不是透析前的SBP目标<140 mmHg HD 患者。这项研究产生的数据将为下一步的几个步骤奠定基础，包括较大的， 多中心试验使用不同的家庭BP目标测试治疗，以降低HD的CVD和死亡率 患者以及实施科学试验将家庭BP测量纳入临床护理。