A double-blind, randomized, parallel, placebo-controlled study examining the
effect of cross-linked polyelectrolyte in heart failure patients with chronic
kidney disease.
Author(s): Costanzo MR, Heywood JT, Massie BM, Iwashita J, Henderson L, Mamatsashvili M,
Sisakian H, Hayrapetyan H, Sager P, van Veldhuisen DJ, Albrecht D.
Affiliation(s): Midwest Heart Foundation, Edward Heart Hospital, P.O. Box 3226, Naperville, IL
60566, USA. mariarosa.costanzo@advocatehealth.com
Publication date & source: 2012, Eur J Heart Fail. , 14(8):922-30
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.
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