PMID- 22613585 OWN - NLM STAT- MEDLINE DCOM- 20121207 LR - 20140731 IS - 1879-0844 (Electronic) IS - 1388-9842 (Linking) VI - 14 IP - 8 DP - 2012 Aug TI - A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectrolyte in heart failure patients with chronic kidney disease. PG - 922-30 LID - 10.1093/eurjhf/hfs074 [doi] AB - AIMS: 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). METHODS AND 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). CONCLUSION: In advanced, symptomatic HF with CKD, CLP is associated with beneficial clinical effects without significant serum potassium changes. TRIAL REGISTRATION: NCT01265524. FAU - Costanzo, Maria Rosa AU - Costanzo MR AD - Midwest Heart Foundation, Edward Heart Hospital, P.O. Box 3226, Naperville, IL 60566, USA. mariarosa.costanzo@advocatehealth.com FAU - Heywood, J Thomas AU - Heywood JT FAU - Massie, Barry M AU - Massie BM FAU - Iwashita, Julie AU - Iwashita J FAU - Henderson, Lee AU - Henderson L FAU - Mamatsashvili, Merab AU - Mamatsashvili M FAU - Sisakian, Hamayak AU - Sisakian H FAU - Hayrapetyan, Hamlet AU - Hayrapetyan H FAU - Sager, Philip AU - Sager P FAU - van Veldhuisen, Dirk J AU - van Veldhuisen DJ FAU - Albrecht, Detlef AU - Albrecht D LA - eng SI - ClinicalTrials.gov/NCT01265524 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20120521 PL - England TA - Eur J Heart Fail JT - European journal of heart failure JID - 100887595 RN - 0 (Cross-Linking Reagents) RN - 0 (Electrolytes) RN - 0 (Mineralocorticoid Receptor Antagonists) RN - 0 (Sodium Potassium Chloride Symporter Inhibitors) RN - 27O7W4T232 (Spironolactone) RN - RWP5GA015D (Potassium) SB - IM CIN - Eur J Heart Fail. 2012 Aug;14(8):870-2. PMID: 22736738 MH - Aged MH - Aged, 80 and over MH - *Cross-Linking Reagents MH - Double-Blind Method MH - *Electrolytes MH - Exercise Test MH - Female MH - Heart Failure/*drug therapy/pathology/psychology MH - Humans MH - Kidney Failure, Chronic/*pathology MH - Male MH - Middle Aged MH - Mineralocorticoid Receptor Antagonists/therapeutic use MH - Potassium/*blood MH - Quality of Life/psychology MH - Sodium Potassium Chloride Symporter Inhibitors/therapeutic use MH - Spironolactone/therapeutic use EDAT- 2012/05/23 06:00 MHDA- 2012/12/12 06:00 CRDT- 2012/05/23 06:00 PHST- 2012/05/23 06:00 [entrez] PHST- 2012/05/23 06:00 [pubmed] PHST- 2012/12/12 06:00 [medline] AID - hfs074 [pii] AID - 10.1093/eurjhf/hfs074 [doi] PST - ppublish SO - Eur J Heart Fail. 2012 Aug;14(8):922-30. doi: 10.1093/eurjhf/hfs074. Epub 2012 May 21.