FP079BLOOD PRESSURE IN DIALYSIS PILOT STUDY DEMONSTRATES FEASIBILITY OF A FULL-SCALE RANDOMIZED CLINICAL TRIAL OF INTENSIVE VS. USUAL CONTROL OF BP IN HYPERTENSIVE HEMODIALYSIS PATIENTS

Abstract

Introduction and Aims: The optimal blood pressure (BP) target for hemodialysis (HD) patients is unknown. Current guidelines have been extrapolated from data in the general population. The Blood Pressure in Dialysis (BID) study randomized patients to a predialysis systolic BP to 110-140 or 155-165 mm Hg. BID is funded by the National institutes of Health (NIH) and Dialysis Clinic Inc. BID goals are to assess the feasibility and inform the design of a full-scale randomized clinical trail (RCT). BID is powered to detect a difference in the change in left ventricular mass, assessed by MRI, across study arms during the 1-year intervention period. BID answers the following questions, which facilitate planning the full-scale RCT: (1) Can we recruit & randomize patients and obtain adequate BP separation between study arms? (2) What BP measurement(s) should guide therapy? (3)Will participants obtain cardiac MRI at the start and end of the intervention? (4) Is the frequency of serious adverse events acceptable? Methods: We recruited patients from Albuquerque, Boston, Charleston, Pittsburgh, and Cleveland. The MRI Reading Center and Data Coordinating Center are at Brigham &Women's Hospital and Cleveland Clinic, respectively. Predialysis SBP measurements (SDUSBPM), in accord with American Heart Association guidelines, guide therapy. We also obtain home BP measurements (HBPM) and ABPM. A 2-week running mean SDUSBPM ≥ 155 mm Hg was required for randomization. Results: There were 143 dropouts during baseline. Major reasons included two week mean SDUSBPM < 155 mm Hg (43.4%), no cardiac MRI (7.0%) and changed mind about participation (25.2%). However, we randomized the pre-specified randomization target (n=120). We achieved separation in SDUSBPM between study arms but the time participants were in their respective target ranges was low. Reasons that participants in the intensive goal did not sustain the target SDUSBPM were high interdialytic weight gain (27.2%), non-adherence with medications or dialysis prescription (40.9%) and intradialytic hypotension (31.9%). On average ABPM were lower than SDUSBPM but higher than HBPM. Differences were often ≥ 10 mm Hg. Optimal control of BP likely requires multiple types of measurements. The rate of serious adverse events was not higher than that observed in other NIH-funded studies of HD patients. Conclusions: It is feasible to conduct a full-scale clinical trial of intensive versus usual treatment of hypertension in HD patients. (Figure presented).