Rationale and design of the treatment of hyponatremia based on Lixivaptan in NYHA class III/IV cardiac patient evaluation (THE BALANCE) study

William T. Abraham, Juan M. Aranda, John P. Boehmer, Uri Elkayam, Edward M. Gilbert, Stephen S. Gottlieb, Gerd Hasenfub, Marrick Kukin, Brian D. Lowes, John B. O'Connell, Luigi Tavazzi, Arthur M. Feldman, Barry Ticho, Cesare Orlandi

Research output: Contribution to journalArticle

18 Scopus citations

Abstract

Hyponatremia is a common electrolyte disorder in patients with heart failure (HF) associated with cognitive dysfunction and increased mortality and rehospitalization rates. Loop diuretics worsen renal function, produce neurohormonal activation, and induce electrolyte imbalances. Lixivaptan is a selective, oral vasopressin V2-receptor antagonist that improves hyponatremia by promoting electrolyte-free aquaresis without significant side effects. The Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation (BALANCE) study is a randomized, double-blind, placebo-controlled, phase 3 trial designed to evaluate the effects of lixivaptan on serum sodium in patients hospitalized with worsening heart failure (target N= 650), signs of congestion and serum sodium concentrations <135 mEq/L. Other endpoints include assessment of dyspnea, body weight, cognitive function, and days of hospital-free survival. Patients are randomized 1:1 to lixivaptan or matching placebo for 60 days, with a 30-day safety follow-up. Doses of lixivaptan or placebo are adjusted based on serum sodium and volume status. Lixivaptan was shown to increase serum sodium and reduce body weight, without renal dysfunction or hypokalemia. BALANCE seeks to address unmet questions regarding the use of vasopressin antagonists including their effects on cognitive function and clinical outcomes in patients with hyponatremia and worsening heart failure.

Original languageEnglish (US)
Pages (from-to)249-253
Number of pages5
JournalClinical and Translational Science
Volume3
Issue number5
DOIs
Publication statusPublished - Oct 1 2010

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Keywords

  • Arginine vasopressin
  • Heart failure
  • Hyponatremia

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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