title: Design of the Blood Pressure Goals in Dialysis pilot study.
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.
authors: Department of Medicine (AG, AH, BH, EB, PZ), University of New Mexico, Albuquerque, New Mexico; Department of Medicine (DM), Tufts University, Boston, Massachusetts; Department of Quantitative Health Sciences (JG), Cleveland Clinic Foundation, Cleveland, Ohio; Department of Medicine (JC), Boston University, Boston, Massachusetts; Dialysis Clinic, Inc (SP, PZ), Quality Management, Albuquerque, New Mexico; National Institutes of Health (JWK), NIDDK, Bethesda, Maryland; and Department of Medicine (MU), University of Pittsburgh, Pittsburgh, Pennsylvania.
authors: Ambreen
authors: A
authors: Gul
authors: Dana
authors: D
authors: Miskulin
authors: Jennifer
authors: J
authors: Gassman
authors: Antonia
authors: A
authors: Harford
authors: Bruce
authors: B
authors: Horowitz
authors: Joline
authors: J
authors: Chen
authors: Susan
authors: S
authors: Paine
authors: Edward
authors: E
authors: Bedrick
authors: John W
authors: JW
authors: Kusek
authors: Mark
authors: M
authors: Unruh
authors: Philip
authors: P
authors: Zager
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D010865:Pilot Projects; D006435:Renal Dialysis; D012107:Research Design
chemical_list: D000959:Antihypertensive Agents
references: Kidney Int. 1998 Aug;54(2):561-9
references: 9690224
references: Kidney Int. 2008 Sep;74(6):791-8
references: 18596733
references: Lancet. 1998 Jun 13;351(9118):1755-62
references: 9635947
references: Hypertension. 2005 Apr;45(4):811-7
references: 15699452
references: Hypertension. 2010 Feb;55(2):305-11
references: 20038754
references: Am J Kidney Dis. 2002 Jun;39(6):1226-30
references: 12046035
references: Hypertension. 1995 Mar;25(3):305-13
references: 7875754
references: Hypertension. 2006 Jan;47(1):62-8
references: 16344376
references: Hypertension. 2009 May;53(5):860-6
references: 19273737
references: Clin J Am Soc Nephrol. 2006 Sep;1(5):952-9
references: 17699312
references: N Engl J Med. 2006 Nov 16;355(20):2071-84
references: 17108342
references: Circulation. 2003 Oct 28;108(17):2154-69
references: 14581387
references: J Pain Symptom Manage. 1997 Feb;13(2):63-74
references: 9095563
references: N Engl J Med. 2002 Dec 19;347(25):2010-9
references: 12490682
references: JAMA. 2007 Sep 19;298(11):1291-9
references: 17878421
references: Am J Med. 2003 Sep;115(4):291-7
references: 12967694
references: Clin J Am Soc Nephrol. 2008 Sep;3(5):1407-14
references: 18701616
references: N Engl J Med. 2005 Jul 21;353(3):238-48
references: 16034009
references: Clin J Am Soc Nephrol. 2007 Nov;2(6):1228-34
references: 17942773
references: Circulation. 1996 Feb 15;93(4):697-703
references: 8640998
references: Am J Kidney Dis. 1999 Apr;33(4):682-7
references: 10196009
references: Clin Pharmacol Ther. 1978 Mar;23(3):361-70
references: 627144
references: J Hypertens. 1999 Dec;17(12 Pt 1):1751-8
references: 10658942
references: Nephrol Dial Transplant. 2007 Apr;22(4):1198-204
references: 17255132
references: N Engl J Med. 1998 Aug 27;339(9):584-90
references: 9718377
references: Kidney Int. 1992 May;41(5):1286-91
references: 1614043
references: Kidney Int. 2003 Aug;64(2):649-56
references: 12846762
references: J Am Soc Nephrol. 2007 Aug;18(8):2377-84
references: 17634440
references: Lancet. 2009 Mar 21;373(9668):1009-15
references: 19249092
references: N Engl J Med. 2010 Dec 9;363(24):2287-300
references: 21091062
references: J Am Soc Nephrol. 2006 Feb;17(2):513-20
references: 16396968
references: Hypertension. 2005 Apr;45(4):592-6
references: 15753232
references: Kidney Int. 1996 May;49(5):1379-85
references: 8731103
references: JAMA. 1968 Mar 11;203(11):922-6
references: 5694313
references: Support Care Cancer. 2011 Sep;19(9):1441-50
references: 20706850
references: J Hum Hypertens. 2011 Feb;25(2):98-105
references: 20410919