title: Protocol of randomized control trial for effectiveness of angiotensin receptor blockers on blood pressure control among euvolemic hypertensive hemodialysis patients.
abstract: BACKGROUND
  Volume overload and the renin-aldosterone-angiotensin system (RAAS) are 2 major factors contributing to hypertension (HTN) among hemodialysis (HD) patients. Although volume-dependent components of HTN can be corrected by appropriate volume removal, a proportion of HD patients experience elevated blood pressure (BP) despite achieving euvolemic and ideal dry weight.
  
  
  METHODS
  A single center, prospective, randomized, parallel design, single-blind trial will be conducted in the Malaysian state of Kelantan among postdialysis euvolemic hypertensive patients that are on regular dialysis at least 3 times a week. The primary outcome of the trial will be to note the effectiveness of losartan (RAAS inhibitor) in reducing systolic BP < 140 mm Hg compared to standard non-RAAS-inhibitor antihypertensive therapy. The secondary outcome will be to look at all causes of mortality. A body composition monitor (BCM) will be used to assess postdialysis volume and dry weight. Postdialysis euvolemic patients that have systolic BP > 140 mm Hg will be randomized using Covariate Adaptive Randomization to standard or treatment arm. Participants in the treatment arm will be given 50 mg of losartan once daily except on dialysis days, whereas the standard arm patients will be prescribed non-RAAS antihypertensive agents. The study participants will be followed for a period of 12 months. A Wilcoxon statistical test will be performed to note the difference in BP from baseline up to 12 months using Statistical Package for the Social Sciences (SPSS) 20.
  The study protocols are approved from the Ethical and Research Committee of the Universiti Sains Malaysia (USM/JEPeM/15050173). The trial is registered under the Australia New Zealand Clinical Trial Registry (ACTRN12615001322527). The trial was registered on 2/12/2015 and the 1st patient was enrolled on 10/12/2015. The trial was formally initiated on 16/02/2016.
  
  
  CONCLUSIONS
  Management of HTN among HD patients requires understanding the primary cause of HTN and treating accordingly. The current trial is an attempt to reduce BP among postdialysis euvolemic but hypertensive patients.
authors.affiliation: Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang CKD Resource Centre, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan School of Pharmacy, Monash University, Jalan Lagoon Selatan, Bandar Sunway, Selangor, Malaysia.
authors.forename: Raja Ahsan
authors.initials: RA
authors.lastname: Aftab
authors.forename: Amer Hayat
authors.initials: AH
authors.lastname: Khan
authors.forename: Syed Azhar
authors.initials: SA
authors.lastname: Syed Sulaiman
authors.forename: Tahir Mehmood
authors.initials: TM
authors.lastname: Khan
authors.forename: Azreen Syazril
authors.initials: AS
authors.lastname: Adnan
mesh_terms: D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use*; D002985:Clinical Protocols; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007676:Kidney Failure, Chronic / Q000150:complications*; D006435:Renal Dialysis
chemical_list: D057911:Angiotensin Receptor Antagonists