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: Tsuyoshi Shinozaki, Jun Watanabe, Junichi Kikuchi, Kenji Tamaki, Nobuo Hoshi, Masato Hayashi, Yukio Onodera, Tetsuya Hiramoto, Jun Ikeda, Masahito Sakuma, Mitsumasa Fukuchi, Masafumi Sugi, Yutaka Kagaya, Kunio Shirato, DIAST Investigators
• Journal: Circulation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 68 Issue 7 Pg. 660-4 (Jul 2004) ISSN: 1346-9843 [Print] Japan
• PMID: 15226632 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Diastole (physiology)
• Ethics, Medical
• Follow-Up Studies
• Heart Failure (mortality, physiopathology)
• Humans
• Japan
• Patient Readmission (statistics & numerical data)
• Survival Analysis