title: A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectrolyte in heart failure patients with chronic kidney disease.
abstract: OBJECTIVE
  This double-blind, randomized, parallel, placebo-controlled investigation evaluated the effects of cross-linked polyelectrolyte (CLP) on serum potassium and measures of congestion in patients with heart failure (HF) and chronic kidney disease (CKD).
  
  
  RESULTS
  The primary endpoint was change in serum potassium over time. Exploratory endpoints included: weight, physician and patient assessment of exertional dyspnoea, effect on N-terminal pro brain natriuretic peptide (NT-proBNP) levels, New York Heart Association (NYHA) classification, 6 min walk test (6MWT), and quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ). Serum potassium was similar in CLP (n =59) and placebo (n =52) groups throughout the 8-week study. Weight loss was greater in the CLP than in the placebo group at Weeks 1 (P =0.014) and 2 (P =0.004), and this trend continued until the end of the study. After 8 weeks, by physician assessment, the percentage of patients experiencing marked or disabling dyspnoea tended to be lower in the CLP than in the placebo group (7.3% vs. 23.9%, P =0.128). Fewer patients in the CLP than in the placebo group had NT-proBNP levels >1000 pg/mL at Week 4 (P =0.039) and Week 8 (P =0.065). The proportion of patients improving by at least one NYHA functional class over the study was higher in the CLP than in the placebo group (48.8% vs. 17.4%; P =0.002). Effects on 6MWT at Week 8 (p =0.072) and quality of life (overall KCCQ score) at Week 4 (p =0.005) and 8 (P =0.062) all favoured the CLP cohort. Four treatment-unrelated deaths occurred in the CLP group and none in the placebo group (P =0.056).
  
  
  CONCLUSIONS
  In advanced, symptomatic HF with CKD, CLP is associated with beneficial clinical effects without significant serum potassium changes.
  
  
  BACKGROUND
  NCT01265524.
authors.affiliation: Midwest Heart Foundation, Edward Heart Hospital, P.O. Box 3226, Naperville, IL 60566, USA. mariarosa.costanzo@advocatehealth.com
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Costanzo
authors.forename: J Thomas
authors.initials: JT
authors.lastname: Heywood
authors.forename: Barry M
authors.initials: BM
authors.lastname: Massie
authors.forename: Julie
authors.initials: J
authors.lastname: Iwashita
authors.forename: Lee
authors.initials: L
authors.lastname: Henderson
authors.forename: Merab
authors.initials: M
authors.lastname: Mamatsashvili
authors.forename: Hamayak
authors.initials: H
authors.lastname: Sisakian
authors.forename: Hamlet
authors.initials: H
authors.lastname: Hayrapetyan
authors.forename: Philip
authors.initials: P
authors.lastname: Sager
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Veldhuisen
authors.forename: Detlef
authors.initials: D
authors.lastname: Albrecht
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003432:Cross-Linking Reagents; D004311:Double-Blind Method; D004573:Electrolytes; D005080:Exercise Test; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D006801:Humans; D007676:Kidney Failure, Chronic / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use; D011188:Potassium / Q000097:blood*; D011788:Quality of Life / Q000523:psychology; D049994:Sodium Potassium Chloride Symporter Inhibitors / Q000627:therapeutic use; D013148:Spironolactone / Q000627:therapeutic use
chemical_list: D003432:Cross-Linking Reagents; D004573:Electrolytes; D000451:Mineralocorticoid Receptor Antagonists; D049994:Sodium Potassium Chloride Symporter Inhibitors; D013148:Spironolactone; D011188:Potassium