title: Effect of tolvaptan on acute heart failure with hyponatremia--a randomized, double blind, controlled clinical trial.
abstract: OBJECTIVE
  To assess the efficacy of tolvaptan in acute heart failure with hyponatremia using a randomized double-blinded placebo-controlled study design.
  
  
  BACKGROUND
  Tolvaptan is a selective vasopressin receptor 2 antagonist. There are no published clinical trials on the utility of tolvaptan in acute heart failure with hyponatremia in the Indian population.
  
  
  METHODS
  After screening and informed consent, 51 HF patients with hyponatremia were randomized using computer-generated randomization sequence to receive placebo or 15mg of tolvaptan for 5 days along with conventional medical therapy. The patient's perception of dyspnea using Likert score and the plasma sodium was measured at baseline and for the next 4 days.
  
  
  RESULTS
  There was a mean improvement in sodium concentration by 5mEq/L (p=0.001) in patients receiving tolvaptan, whereas no significant improvement was seen in the placebo group (p=0.33). Significant improvement in Likert score was observed in both the groups (p=0.001), even though there was no difference between both the groups. Dry mouth and thirst were the most commonly occurring adverse effects observed in both the groups. There were no significant hemodynamic changes with tolvaptan therapy.
  
  
  CONCLUSIONS
  Tolvaptan at a dose of 15mg is effective in reversing hyponatremia in acute heart failure and may be a suitable option in these patients.
authors.affiliation: Department of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
authors.forename: Elangovan
authors.initials: E
authors.lastname: Shanmugam
authors.affiliation: Department of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
authors.forename: C R Madhu Prabhu
authors.initials: CR
authors.lastname: Doss
authors.affiliation: Department of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India. Electronic address: melvingeorge2003@gmail.com.
authors.forename: Melvin
authors.initials: M
authors.lastname: George
authors.affiliation: Department of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
authors.forename: Amrita
authors.initials: A
authors.lastname: Jena
authors.affiliation: Department of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
authors.forename: Muthukumar
authors.initials: M
authors.lastname: Rajaram
authors.affiliation: Department of Community Medicine, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
authors.forename: Balaji
authors.initials: B
authors.lastname: Ramaraj
authors.affiliation: Department of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
authors.forename: Karthik
authors.initials: K
authors.lastname: Anjaneyan
authors.affiliation: Department of Cardiology, SRM Medical College Hospital & Research Centre, Kattankulathur, Chennai, Tamil Nadu 603203, India.
authors.forename: B
authors.initials: B
authors.lastname: Kanagesh
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D065092:Antidiuretic Hormone Receptor Antagonists / Q000008:administration & dosage; D001552:Benzazepines / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007010:Hyponatremia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D012964:Sodium / Q000097:blood*; D000077602:Tolvaptan; D016896:Treatment Outcome
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D000077602:Tolvaptan; D012964:Sodium
keywords: Dyspnea; Heart failure; Hyponatremia; Randomized clinical trial; Tolvaptan