Investigation of the optimal treatment strategy for atrial fibrillation in Japan.
The Japanese Rhythm Management Trial for Atrial Fibrillation (J-RHYTHM study) is a randomized comparative evaluation of rate control and rhythm control, both combined with antithrombotic therapy, as therapeutic strategies for the treatment of atrial fibrillation (AF). This study differs from the earlier AFFIRM and RACE studies in that it has a composite primary end-point representing mortality and also physical/psychological disablement (total mortality, symptomatic cerebral infarction, systemic embolism, major bleeding, hospitalization for heart failure requiring intravenous administration of diuretics, and patient disablement). Patients' will to change the therapeutic strategy to the other is also considered as an end-point representing disablement under the assigned strategy. The secondary end-point includes quality of life scores and the efficacy and safety of drugs used in treating AF. The J-RHYTHM study emphasizes patient-reported experience and perception of AF-specific disablement, and the safety of antiarrhythmics available in Japan; it will follow 2600 patients treated at more than 150 sites in Japan for a 3-year period.
Yamashita
Takeshi
T
J-RHYTHM Clinical Trial Center, The Cardiovascular Institute, Tokyo, Japan.
Ogawa
Satoshi
S
Aizawa
Yoshifusa
Y
Atarashi
Hirotsugu
H
Inoue
Hiroshi
H
Ohe
Tohru
T
Okumura
Ken
K
Kato
Takao
T
Kamakura
Shiro
S
Kumagai
Koichiro
K
Kurachi
Yoshihisa
Y
Kodama
Itsuo
I
Koretsune
Yukihiro
Y
Saikawa
Tetsunori
T
Sakurai
Masayuki
M
Sugi
Kaoru
K
Nakaya
Haruaki
H
Nakayama
Toshio
T
Hirai
Makoto
M
Fukatani
Masahiko
M
Mitamura
Hideo
H
Yamazaki
Tsutomu
T
D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology / Q000523:psychology; D004359:Drug Therapy, Combination; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006339:Heart Rate; D006801:Humans; D007564:Japan; D011788:Quality of Life; D012107:Research Design
D000889:Anti-Arrhythmia Agents; D005343:Fibrinolytic Agents