title: Clinical Effectiveness of Tolvaptan in Patients With Acute Heart Failure and Renal Dysfunction.
abstract: BACKGROUND
  More efficacious and/or safer decongestive therapy is clearly needed in acute heart failure (AHF) patients complicated by renal dysfunction. We tested the hypothesis that adding tolvaptan, an oral vasopressin-2 receptor antagonist, to conventional therapy with loop diuretics would be more effective treatment in this population.
  
  
  RESULTS
  A multicenter, open-label, randomized control trial was performed, and 217 AHF patients with renal dysfunction (estimated glomerular filtration rate 15-60 mL • min(-1) • 1.73 m(-2)) were randomized 1:1 to treatment with tolvaptan (n=108) or conventional treatment (n=109). The primary end point was 48-hour urine volume. The tolvaptan group showed more diuresis than the conventional treatment group (6464.4 vs 4999.2 mL; P <.001) despite significantly lower amounts of loop diuretic use (80 mg vs 120 mg; P <.001). Dyspnea relief was achieved significantly more frequently in the tolvaptan group at all time points within 48 hours except 6 hours after enrollment. The rate of worsening of renal function (≥0.3 mg/dL increase from baseline) was similar between the tolvaptan and conventional treatment groups (24.1% vs 27.8%, respectively; P =.642).
  
  
  CONCLUSIONS
  Adding tolvaptan to conventional treatment achieved more diuresis and relieved dyspnea symptoms in AHF patients with renal dysfunction.
  
  
  BACKGROUND
  URL: http://www.umin.ac.jp/ctr/index/htm/ Unique identifier: UMIN000007109.
authors.affiliation: Department of Cardiology, Kameda Medical Center, Chiba, Japan. Electronic address: yuya8950@gmail.com.
authors.forename: Yuya
authors.initials: Y
authors.lastname: Matsue
authors.affiliation: Department of Cardiology, Kameda Medical Center, Chiba, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Suzuki
authors.affiliation: Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan.
authors.forename: Sho
authors.initials: S
authors.lastname: Torii
authors.affiliation: Department of Cardiology, Tomishiro Central Hospital, Okinawa, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yamaguchi
authors.affiliation: Department of Cardiology, Tokyo Metropolitan Hiroo Hospital, Tokyo, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Fukamizu
authors.affiliation: Department of Cardiology, Ome Municipal General Hospital, Tokyo, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ono
authors.affiliation: Department of Cardiology, Yokohama Minami Kyosai Hospital, Kanagawa, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujii
authors.affiliation: Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kitai
authors.affiliation: Department of Cardiology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Nishioka
authors.affiliation: Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Sugi
authors.affiliation: Department of Cardiology, Hiratsuka Kyosai Hospital, Kanagawa, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Onishi
authors.affiliation: Department of Cardiology, Tokyo Yamate Medical Center, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Noda
authors.affiliation: Department of Cardiology, Sakakibara Heart Institute of Okayama, Okayama, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Kagiyama
authors.affiliation: Department of Cardiology, National Disaster Medical Center, Tokyo, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Satoh
authors.affiliation: Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
authors.forename: Kazuki
authors.initials: K
authors.lastname: Yoshida
authors.affiliation: Division of Cardiology, Hennepin County Medical Center and University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Goldsmith
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists / Q000008:administration & dosage; D001552:Benzazepines / Q000008:administration & dosage*; D004231:Diuresis / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005919:Glomerular Filtration Rate; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D000077602:Tolvaptan; D016896:Treatment Outcome
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D000077602:Tolvaptan
keywords: Vasopressin antagonist; acute heart failure; renal function