Design of the blood pressure goals in dialysis pilot study

Ambreen Gul, Dana Miskulin, Jennifer Gassman, Antonia Harford, Bruce Horowitz, Joline Chen, Susan Paine, Edward Bedrick, John W. Kusek, Mark Unruh, Philip Zager

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Background: Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general population. Existing randomized controlled trials (RCTs) were small and did not include prespecified BP targets. METHODS:: The authors described the design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT where HD patients are randomized to either a target-standardized predialysis SBP of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD patients to 2 different SBP targets. RESULTS:: Primary outcomes are feasibility and safety. Feasibility parameters include recruitment and retention rates, adherence with prescribed BP measurements and achievement and maintenance of selected BP targets. Safety parameters include rates of hypotension and other adverse and serious adverse events. The authors obtained preliminary data on changes in left ventricular mass, aortic pulse wave velocity, vascular access thromboses and health-related quality of life across study arms, which may be the secondary outcomes in the full-scale study. CONCLUSIONS:: The data acquired in the pilot RCT will determine the feasibility and safety and inform the design of a full-scale trial, powered for hard outcomes, which may require 2000 participants.

Original languageEnglish (US)
Pages (from-to)125-130
Number of pages6
JournalAmerican Journal of the Medical Sciences
Volume347
Issue number2
DOIs
StatePublished - 2014
Externally publishedYes

Keywords

  • Blood pressure
  • Cardiac MRI
  • Dialysis
  • Randomized controlled trial

ASJC Scopus subject areas

  • Medicine(all)

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