title: Rationale, design, and organization of the Diastolic Heart Failure Assessment Study in Tohoku District (DIAST).
abstract: BACKGROUND
  High mortality and a high readmission rate characterize diastolic heart failure (DHF), but evidence-based therapeutic strategies have not been established for DHF.
  
  
  METHODS
  The aim of a multicenter, randomized open trial (the Diastolic Heart Failure Assessment Study in Tohoku District, DIAST) is to evaluate the safety and prognostic efficacy of the multiple action non-selective beta-blocker carvedilol in 160 patients with DHF (left-ventricular ejection fraction > or =50%). The target dose of carvedilol is 10 mg twice a day and the mean follow-up is estimated to be 2 years. The primary endpoints are to evaluate (1) all-cause mortality or hospitalization, (2) cardiovascular mortality or hospitalization and (3) worsening heart failure. The secondary endpoints are to assess (1) cardiovascular events, (2) the individual components of the above combined endpoints, (3) the duration of hospitalization, (4) the functional class and exercise capacity and (5) the safety and tolerability. All patients' data are processed using an original registration system on an internet homepage. Several substudies to assess neurohumoral factors, heart rate variability, oxidative stress and sleep apnea will clarify the pathophysiology of DHF.
  
  
  CONCLUSIONS
  The DIAST will contribute to establish therapeutic guidelines for DHF.
authors.affiliation: Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Shinozaki
authors.forename: Jun
authors.initials: J
authors.lastname: Watanabe
authors.forename: Junichi
authors.initials: J
authors.lastname: Kikuchi
authors.forename: Kenji
authors.initials: K
authors.lastname: Tamaki
authors.forename: Nobuo
authors.initials: N
authors.lastname: Hoshi
authors.forename: Masato
authors.initials: M
authors.lastname: Hayashi
authors.forename: Yukio
authors.initials: Y
authors.lastname: Onodera
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hiramoto
authors.forename: Jun
authors.initials: J
authors.lastname: Ikeda
authors.forename: Masahito
authors.initials: M
authors.lastname: Sakuma
authors.forename: Mitsumasa
authors.initials: M
authors.lastname: Fukuchi
authors.forename: Masafumi
authors.initials: M
authors.lastname: Sugi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kagaya
authors.forename: Kunio
authors.initials: K
authors.lastname: Shirato
mesh_terms: D003971:Diastole / Q000502:physiology*; D004992:Ethics, Medical; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology*; D006801:Humans; D007564:Japan; D010359:Patient Readmission / Q000706:statistics & numerical data; D016019:Survival Analysis