BP in Dialysis: Results of a Pilot Study

Abstract

The optimal BP target for patients receiving hemodialysis is unknown. We randomized 126 hypertensive patients on hemodialysis to a standardized predialysis systolic BP of 110-140 mmHg (intensive arm) or 155-165 mmHg (standard arm). The primary objectives were to assess feasibility and safety and inform the design of a full-scale trial. A secondary objective was to assess changes in left ventricular mass. Median follow-up was 365 days. In the standard arm, the 2-week moving average systolic BP did not change significantly during the intervention period, but in the intensive arm, systolic BP decreased from 160 mmHg at baseline to 143 mmHg at 4.5 months. From months 4-12, the mean separation in systolic BP between arms was 12.9 mmHg. Four deaths occurred in the intensive arm and one death occurred in the standard arm. The incidence rate ratios for the intensive compared with the standard arm (95% confidence intervals) were 1.18 (0.40 to 3.33), 1.61 (0.87 to 2.97), and 3.09 (0.96 to 8.78) for major adverse cardiovascular events, hospitalizations, and vascular access thrombosis, respectively. The intensive and standard arms had similar median changes (95% confidence intervals) in left ventricular mass of -0.84 (-17.1 to 10.0) g and 1.4 (-11.6 to 10.4) g, respectively. Although we identified a possible safety signal, the small size and short duration of the trial prevent definitive conclusions. Considering the high risk for major adverse cardiovascular events in patients receiving hemodialysis, a full-scale trial is needed to assess potential benefits of intensive hypertension control in this population.

Trial registration: ClinicalTrials.gov NCT01421771.

Keywords: blood pressure; hemodialysis; hypertension; randomized controlled trials.

Graphical abstract

Figure 1.

Consort diagram showing participant flow from enrollment to randomization, follow-up, and analysis. F12, month 12 post randomization; LV, left ventricular; SDUSBP, standardized dialysis unit systolic blood pressure.

Figure 2.

Standardized dialysis unit and home SBP and mean number of antihypertensive medications. (A) Fitted values for 2-week moving averages of SBP measured in the dialysis unit. (B) Fitted values for 2-week moving averages of SBP measured at home. (C) Mean number of antihypertensive medications throughout the intervention period.