Japanese randomized trial for investigation of a combined therapy of amiodarone and implantable cardioverter defibrillator in patients with ventricular tachycardia and fibrillation: the Nippon ICD Plus Pharmachologic Option Necessity study design.
BACKGROUND
Implantable cardioverter-defibrillators (ICDs) are the most effective therapy in reducing the mortality of patients with life-threatening ventricular tachyarrhythmias. However, the ICD cannot prevent the recurrence of tachycarida attacks and that limits the clinical usefulness of them. The Nippon ICD Plus Pharmachologic Option Necessity (NIPPON) trial was designed as the first prospective randomized study to test the hypothesis whether amiodarone could improve the patient's clinical outcome by reducing the amount of ICD therapy in the Japanese patient population.


RESULTS
Approximately 400 patients with organic heart disease and spontaneous episode(s) of sustained ventricular tachycardia/fibrillation (VT/VF) will be randomly assigned to one of 2 groups; the amiodarone group and non-amiodarone group. Both groups of patients will be followed at least for 24 months. The end-point committee will adjudicate events in a blinded fashion. The primary end-points of this study are determination of the appropriate therapy from the ICD and alteration of the assigned treatment because of its harmful effects and/or frequent ICD therapies.


CONCLUSIONS
The NIPPON study is expected to confirm our understanding of the prognostic and therapeutic usefulness of adjuvant amiodarone therapy for patients with an ICD and with a history of sustained VT/VF.
Kurita
Takashi
T
Department of Cardiovascular Medicine, National Cardiovascular Center, Suita, Japan. kuritat@hsp.ncvc.go.jp
Mitamura
Hideo
H
Aizawa
Yoshifusa
Y
Nitta
Takashi
T
Aonuma
Kazutaka
K
Tsuboi
Naoya
N
Chinushi
Masaomi
M
Kobayashi
Yoshinori
Y
Soejima
Kyoko
K
Satomi
Kazuhiro
K
Furushima
Hiroshi
H
Ohe
Tohru
T
Ogawa
Satoshi
S
Kodama
Itsuo
I
Ohtsu
Hiroshi
H
Yamazaki
Tsutomu
T
D000638:Amiodarone / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D017147:Defibrillators, Implantable; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007564:Japan; D011446:Prospective Studies; D012107:Research Design; D055502:Secondary Prevention; D017180:Tachycardia, Ventricular / Q000453:epidemiology / Q000628:therapy*; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000453:epidemiology / Q000628:therapy*
D000889:Anti-Arrhythmia Agents; D000638:Amiodarone