title: Rationale and design of a randomized trial to assess the effects of beta-blocker in diastolic heart failure; Japanese Diastolic Heart Failure Study (J-DHF).
abstract: BACKGROUND
  Heart failure consists of two phenotypes: systolic heart failure and diastolic heart failure (DHF). A growing body of evidence demonstrated benefits of beta-blocker, angiotensin-converting enzyme inhibitor, and angiotensin II receptor blocker in systolic heart failure; however, evidence leading to therapeutic strategy of DHF is lacking.
  
  
  RESULTS
  The Japanese Diastolic Heart Failure Study (J-DHF) is a multicenter, prospective, randomized trial designed to assess effects of beta-blocker in patients with DHF. A total of 800 patients (400 patients in each group) will be enrolled. The primary outcome is a composite of cardiovascular death and unplanned admission to hospital for congestive heart failure. Other outcomes include all-cause mortality, worsening of the symptoms of heart failure, or a need for modification of the treatment for heart failure. Serial assessment of echocardiographic and neurohumoral parameters and cost analysis of the treatment regimen will be conducted. The follow-up period is a minimum of 2 years.
  
  
  CONCLUSIONS
  This study will provide important evidences for the treatment of DHF.
authors.affiliation: Department of Internal Medicine and Therapeutics, Osaka University Graduate School of Medicine, Yamadaoka, Suita, Japan.
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Hori
authors.forename: Akira
authors.initials: A
authors.lastname: Kitabatake
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsutsui
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Okamoto
authors.forename: Kunio
authors.initials: K
authors.lastname: Shirato
authors.forename: Ryozo
authors.initials: R
authors.lastname: Nagai
authors.forename: Toru
authors.initials: T
authors.lastname: Izumi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yokoyama
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Yasumura
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Ishida
authors.forename: Masunori
authors.initials: M
authors.lastname: Matsuzaki
authors.forename: Takashi
authors.initials: T
authors.lastname: Oki
authors.forename: Michihito
authors.initials: M
authors.lastname: Sekiya
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D003971:Diastole / Q000187:drug effects / Q000502:physiology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects
chemical_list: D000319:Adrenergic beta-Antagonists; D047228:Angiotensin II Type 1 Receptor Blockers; D000806:Angiotensin-Converting Enzyme Inhibitors