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

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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.