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 Citations (Scopus)

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
StatePublished - Oct 1 2010

Fingerprint

Hyponatremia
Sodium
Electrolytes
Heart Failure
Placebos
Serum
Cognition
Therapeutics
Body Weight
Sodium Potassium Chloride Symporter Inhibitors
Kidney
Vasopressin Receptors
Hypokalemia
Dyspnea
lixivaptan
Chemical activation
Safety
Survival
Mortality

Keywords

  • Arginine vasopressin
  • Heart failure
  • Hyponatremia

ASJC Scopus subject areas

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

Cite this

Rationale and design of the treatment of hyponatremia based on Lixivaptan in NYHA class III/IV cardiac patient evaluation (THE BALANCE) study. / Abraham, William T.; Aranda, Juan M.; Boehmer, John P.; Elkayam, Uri; Gilbert, Edward M.; Gottlieb, Stephen S.; Hasenfub, Gerd; Kukin, Marrick; Lowes, Brian D.; O'Connell, John B.; Tavazzi, Luigi; Feldman, Arthur M.; Ticho, Barry; Orlandi, Cesare.

In: Clinical and Translational Science, Vol. 3, No. 5, 01.10.2010, p. 249-253.

Research output: Contribution to journalArticle

Abraham, WT, Aranda, JM, Boehmer, JP, Elkayam, U, Gilbert, EM, Gottlieb, SS, Hasenfub, G, Kukin, M, Lowes, BD, O'Connell, JB, Tavazzi, L, Feldman, AM, Ticho, B & Orlandi, C 2010, 'Rationale and design of the treatment of hyponatremia based on Lixivaptan in NYHA class III/IV cardiac patient evaluation (THE BALANCE) study', Clinical and Translational Science, vol. 3, no. 5, pp. 249-253. https://doi.org/10.1111/j.1752-8062.2010.00217.x
Abraham, William T. ; Aranda, Juan M. ; Boehmer, John P. ; Elkayam, Uri ; Gilbert, Edward M. ; Gottlieb, Stephen S. ; Hasenfub, Gerd ; Kukin, Marrick ; Lowes, Brian D. ; O'Connell, John B. ; Tavazzi, Luigi ; Feldman, Arthur M. ; Ticho, Barry ; Orlandi, Cesare. / Rationale and design of the treatment of hyponatremia based on Lixivaptan in NYHA class III/IV cardiac patient evaluation (THE BALANCE) study. In: Clinical and Translational Science. 2010 ; Vol. 3, No. 5. pp. 249-253.
@article{c616fc2eef46430d92cf8ddda7d0601a,
title = "Rationale and design of the treatment of hyponatremia based on Lixivaptan in NYHA class III/IV cardiac patient evaluation (THE BALANCE) study",
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.",
keywords = "Arginine vasopressin, Heart failure, Hyponatremia",
author = "Abraham, {William T.} and Aranda, {Juan M.} and Boehmer, {John P.} and Uri Elkayam and Gilbert, {Edward M.} and Gottlieb, {Stephen S.} and Gerd Hasenfub and Marrick Kukin and Lowes, {Brian D.} and O'Connell, {John B.} and Luigi Tavazzi and Feldman, {Arthur M.} and Barry Ticho and Cesare Orlandi",
year = "2010",
month = "10",
day = "1",
doi = "10.1111/j.1752-8062.2010.00217.x",
language = "English (US)",
volume = "3",
pages = "249--253",
journal = "Clinical and Translational Science",
issn = "1752-8054",
publisher = "Wiley-Blackwell",
number = "5",

}

TY - JOUR

T1 - Rationale and design of the treatment of hyponatremia based on Lixivaptan in NYHA class III/IV cardiac patient evaluation (THE BALANCE) study

AU - Abraham, William T.

AU - Aranda, Juan M.

AU - Boehmer, John P.

AU - Elkayam, Uri

AU - Gilbert, Edward M.

AU - Gottlieb, Stephen S.

AU - Hasenfub, Gerd

AU - Kukin, Marrick

AU - Lowes, Brian D.

AU - O'Connell, John B.

AU - Tavazzi, Luigi

AU - Feldman, Arthur M.

AU - Ticho, Barry

AU - Orlandi, Cesare

PY - 2010/10/1

Y1 - 2010/10/1

N2 - 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.

AB - 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.

KW - Arginine vasopressin

KW - Heart failure

KW - Hyponatremia

UR - http://www.scopus.com/inward/record.url?scp=78049258954&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=78049258954&partnerID=8YFLogxK

U2 - 10.1111/j.1752-8062.2010.00217.x

DO - 10.1111/j.1752-8062.2010.00217.x

M3 - Article

C2 - 20973922

AN - SCOPUS:78049258954

VL - 3

SP - 249

EP - 253

JO - Clinical and Translational Science

JF - Clinical and Translational Science

SN - 1752-8054

IS - 5

ER -