title: Renal and cardiovascular effects of irbesartan in dialysis patients--a randomized controlled trial protocol (SAFIR study).
abstract: BACKGROUND
  Cardiovascular (CV) events are a major cause of morbidity and mortality in haemodialysis (HD) patients. Hypertension, increased arterial stiffness and left ventricular (LV) hypertrophy are highly prevalent and are often poorly controlled. Volume overload is an important factor and survival could be improved by treatment strategies that preserve residual renal function (RRF), reduce blood pressure, and decrease arterial stiffness and LV hypertrophy. Angiotensin II receptor blocker (ARB) treatment can prevent CV events in patients with hypertension and heart failure. However, few data exist in patients with chronic renal failure and it is not known whether ARB treatment improves clinical outcome in HD patients.
  
  
  METHODS
  This is a randomized, controlled and double-blinded intervention study. A total of 82 HD patients from six Danish HD centres will be treated for a year with an ARB (irbesartan) or placebo. The inclusion criteria are urine output > 300 ml/day, dialysis vintage < 1 year and LV ejection fraction > 30%. The primary outcomes are change in RRF, LV hypertrophy, arterial stiffness and intra-dialytic haemodynamics.
  
  
  CONCLUSIONS
  If ARB-treatment improves RRF and intermediate CV endpoints in a group of newly started HD patients, it may improve the survival for this high risk population.
  
  
  BACKGROUND
  The trial is investigator-initiated, investigator-driven and supported by the Danish Agency for Science, Technology and Innovation and several private foundations.
authors: Department of Renal Medicine, Aarhus University Hospital, Aarhus N, Denmark. cdp@ana.au.dk
authors: Christian Daugaard
authors: CD
authors: Peters
authors: Krista Dybtved
authors: KD
authors: Kjærgaard
authors: Bente
authors: B
authors: Jespersen
authors: Kent Lodberg
authors: KL
authors: Christensen
authors: Jens Dam
authors: JD
authors: Jensen
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000494:pharmacology / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000209:etiology; D017379:Hypertrophy, Left Ventricular / Q000000981:diagnostic imaging / Q000188:drug therapy; D000077405:Irbesartan; D007677:Kidney Function Tests; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D012107:Research Design; D013777:Tetrazoles / Q000494:pharmacology / Q000627:therapeutic use*; D014463:Ultrasonography; D059289:Vascular Stiffness / Q000187:drug effects
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001713:Biphenyl Compounds; D013777:Tetrazoles; D000077405:Irbesartan