title: Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure.
abstract: BACKGROUND
  The oral vasopressin-2 receptor antagonist tolvaptan causes aquaresis in patients with volume overload, potentially facilitating decongestion and improving the clinical course of patients with acute heart failure (AHF).
  
  
  OBJECTIVE
  The TACTICS-HF (Targeting Acute Congestion with Tolvaptan in Congestive Heart Failure) study was conducted to address the acute use of tolvaptan to improve congestion in AHF.
  
  
  METHODS
  The TACTICS-HF study randomized patients (n = 257) within 24 h of AHF presentation in a prospective, double blind, placebo-controlled trial. Patients were eligible regardless of ejection fraction, and were randomized to either 30 mg of tolvaptan or placebo given at 0, 24, and 48 h, with a fixed-dose furosemide regimen as background therapy. The primary endpoint was the proportion of patients considered responders at 24 h. Secondary endpoints included symptom improvement, changes in renal function, and clinical events.
  
  
  RESULTS
  Dyspnea relief by Likert scale was similar between groups at 8 h (25% moderately or markedly improved with tolvaptan vs. 28% placebo; p = 0.59) and at 24 h (50% tolvaptan vs. 47% placebo; p = 0.80). Need for rescue therapy was also similar at 24 h (21% tolvaptan, 18% placebo; p = 0.57). The proportion defined as responders at 24 h (primary study endpoint) was 16% for tolvaptan and 20% for placebo (p = 0.32). Tolvaptan resulted in greater weight loss and net fluid loss compared with placebo, but tolvaptan-treated patients were more likely to experience worsening renal function during treatment. There were no differences in in-hospital or post-discharge clinical outcomes.
  
  
  CONCLUSIONS
  In patients hospitalized with AHF, dyspnea, and congestion, the addition of tolvaptan to a standardized furosemide regimen did not improve the number of responders at 24 h, despite greater weight loss and fluid loss. (Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure [TACTICS-HF]; NCT01644331).
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. Electronic address: michael.felker@duke.edu.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Felker
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.affiliation: Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Robert T
authors.initials: RT
authors.lastname: Cole
authors.affiliation: Department of Medicine, Division of Cardiology, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Kirkwood F
authors.initials: KF
authors.lastname: Adams
authors.affiliation: The Ohio Heart and Vascular Center, The Christ Hospital, Cincinnati, Ohio.
authors.forename: Gregory F
authors.initials: GF
authors.lastname: Egnaczyk
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Mona
authors.initials: M
authors.lastname: Fiuzat
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Chetan B
authors.initials: CB
authors.lastname: Patel
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Melvin
authors.initials: M
authors.lastname: Echols
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Michel G
authors.initials: MG
authors.lastname: Khouri
authors.affiliation: Albert Einstein College of Medicine, Bronx, New York.
authors.forename: James M
authors.initials: JM
authors.lastname: Tauras
authors.affiliation: Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Divya
authors.initials: D
authors.lastname: Gupta
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Pamela
authors.initials: P
authors.lastname: Monds
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Rhonda
authors.initials: R
authors.lastname: Roberts
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: O'Connor
mesh_terms: D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists / Q000627:therapeutic use*; D001552:Benzazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004417:Dyspnea / Q000188:drug therapy; D005260:Female; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000077602:Tolvaptan
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D000077602:Tolvaptan
keywords: acute heart failure; decongestion; outcomes; strategies; volume overload