Treating Home Versus Predialysis Blood Pressure Among In-Center Hemodialysis Patients: A Pilot Randomized Trial

Abstract

Rationale & objective: Observational studies have reported a U-shaped association between blood pressure (BP) before a hemodialysis session and death. In contrast, because a linear association between out-of-dialysis-unit BP and death has been reported, home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home versus predialysis BP in hemodialysis patients.

Study design: A 4-month, parallel, randomized, controlled trial.

Settings & participants: 50 prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomly assigned using 1:1 block randomization, stratified by site.

Interventions: To target home systolic BP (SBP) of 100-<140 mm Hg versus predialysis SBP of 100-<140mm Hg. Home and predialysis SBPs were ascertained every 2 weeks. Dry weight and BP medications were adjusted to reach the target SBP.

Outcomes: Primary outcomes were feasibility, adherence, safety. and tolerability.

Results: 50 of 70 (71%) patients who were approached agreed to participate. All enrollees completed the study except for 1 who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP>200mm Hg; 0.2% vs 0%) or low (defined as<90mm Hg; 1.8% vs 1.2%) predialysis BP readings in the home versus predialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs 16%).

Limitations: Small sample size.

Conclusions: This pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients. Larger trials to test the long-term feasibility, efficacy, and safety of home BP treatment in hemodialysis patients should be conducted.

Funders: National Institutes of Health, Satellite Healthcare, and Northwest Kidney Centers.

Trial registration: Registered at ClinicalTrials.gov with study number NCT03459807.

Keywords: BP management; BP target; Blood pressure (BP); clinical trial; dry weight adjustment; end-stage renal disease (ESRD); hemodialysis; home BP; hypertension; masked hypertension; pilot study; pragmatic trial; white coat effect.

Conflict of interest statement

Peer Review: Received December 16, 2019. Evaluated by 2 external peer reviewers, with direct editorial input from a Statistics/Methods Editor and an International Editor, who served as Acting Editor-in-Chief. Accepted in revised form June 11, 2020. The involvement of an Acting Editor-in-Chief was to comply with AJKD’s procedures for potential conflicts of interest for editors, described in the Information for Authors & Journal Policies.

Copyright © 2020 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1.

Flow diagram of trial participants. Abbreviations: EMR, electronic medical record; SBP, systolic blood pressure.

Figure 2.

Mean predialysis systolic blood pressures (SBPs) over 4 months among participants randomly assigned to the home SBP versus dialysis SBP treatment groups (N = 50). Error bars represent standard deviation.

Figure 3.

Mean home and predialysis systolic blood pressures (SBPs) over 4 months among participants randomly assigned to the home BP treatment group (n = 25). Error bars represent standard deviation.