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 Pharmacologic Option Necessity (NIPPON) Study Design

Takashi Kurita; Hideo Mitamura; Yoshifusa Aizawa; Takashi Nitta; Kazutaka Aonuma; Naoya Tsuboi; Masaomi Chinushi; Yoshinori Kobayashi; Kyoko Soejima; Kazuhiro Satomi; Hiroshi Furushima; Tohru Ohe; Satoshi Ogawa; Itsuo Kodama; Hiroshi Ohtsu; Tsutomu Yamazaki; (Nippon ICD Plus Pharmachologic Option Necessity (NIPPON) Investigators)

doi:10.1253/circj.70.316

Clinical Investigation

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 Pharmacologic Option Necessity (NIPPON) Study Design

Takashi Kurita, Hideo Mitamura, Yoshifusa Aizawa, Takashi Nitta, Kazutaka Aonuma, Naoya Tsuboi, Masaomi Chinushi, Yoshinori Kobayashi, Kyoko Soejima, Kazuhiro Satomi, Hiroshi Furushima, Tohru Ohe, Satoshi Ogawa, Itsuo Kodama, Hiroshi Ohtsu, Tsutomu Yamazaki, (Nippon ICD Plus Pharmachologic Option Necessity (NIPPON) Investigators)

Author information

Takashi Kurita
Department of Cardiovascular Medicine, National Cardiovascular Center
Hideo Mitamura
Department of Cardiology, Saiseikai Central Hospital
Yoshifusa Aizawa
First Department of Internal Medicine, Niigata University School of Medicine
Takashi Nitta
Department of Biological Regulation and Regenerative Surgery, Nippon Medical School, Graduate School of Medicine
Kazutaka Aonuma
Department of Internal Medicine, Cardiovascular Division, University of Tsukuba
Naoya Tsuboi
Department of Cardiology, Social Insurance Chukyo Hospital
Masaomi Chinushi
School of Health Science, Niigata University School of Medicine
Yoshinori Kobayashi
First Department of Internal Medicine, Nippon Medical School
Kyoko Soejima
Cardiopulmonary Division, Keio University School of Medicine
Kazuhiro Satomi
Department of Cardiovascular Medicine, National Cardiovascular Center
Hiroshi Furushima
First Department of Internal Medicine, Niigata University School of Medicine
Tohru Ohe
Department of Cardiovascular Medicine, Okayama University
Satoshi Ogawa
Cardiopulmonary Division, Keio University School of Medicine
Itsuo Kodama
Department of Circulation, Research Institute of Environment Medicine, Nagoya University
Hiroshi Ohtsu
Department of Clinical Bioinformatics, University of Tokyo
Tsutomu Yamazaki
Department of Clinical Bioinformatics, University of Tokyo
(Nippon ICD Plus Pharmachologic Option Necessity (NIPPON) Investigators)

Keywords: Amiodarone, Implantable cardioverter defibrillator, Ventricular fibrillation, Ventricular tachycardia

JOURNAL FREE ACCESS

2006 Volume 70 Issue 3 Pages 316-320

DOI https://doi.org/10.1253/circj.70.316

Details

Abstract

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. Methods and 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. Conclusion 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. (Circ J 2006; 70: 316 - 320)

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