NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000381

Registered date:01/04/2006

Nippon ICD Plus Pharmacologic Option Necessity

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpatients with spontaneous episode(s) of sustained ventricular tachycardia or ventricular fibrillation associated with organic heart disease
Date of first enrollment2006/04/01
Target sample size400
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Amiodarone ICD

Outcome(s)

Primary OutcomePrimary End-Point: The primary end-points of this study are: (1) an appropriate ICD therapy; and (2) an alteration of the assigned treatment because of its harmful effect and/or frequent ICD therapy deliveries (more than 3 sessions of ICD first therapy within 24h). The latter one includes termination of amiodarone or a transition to an alternative antiarrhythmic drug (class I or class III) in the amiodarone group, or curative interventions such as catheter ablation or cryosurgery in either group
Secondary OutcomeSecondary End-Points: The secondary end-points of this study are: (1) total death; (2) arrhythmia death; (3) cardiac death; (4) re-hospitalization aiming to control VT/VF; (5) impairment of patient's QOL; (6) deterioration of heart failure; (7) abnormal increase in the DFT (less than a 10J safety margin); (8) inappropriate ICD therapy; or (9) occurrence of side-effects from amiodarone

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe exclusion criteria for this study are when patients have the following: (1) idiopathic VT/VF; (2) Brugada syndrome; (3) congenital long QT syndrome; (4) an incessant form of VT/VF; (5) VT/VF resulting from a transient or reversible disorder such as acute myocardial infarction, electrolyte imbalance or drugs; (5) are aged less than 20 years old; (6) are taking class I or class III drugs (including amiodarone), which cannot be discontinued; (7) a life ecpectancy less than 2 years; (8) congestive heart failure with a New York Heart Association (NYHA) cardiac function class IV or are candidates for cardiac transplantation; (9) bradycardia less than 50 beats/min.; (10) second- or third-degree atrioventricular block; (11) corrected QT interval equal to or longer than 480ms; (12) significant pulmonary fibrosis, diffusion capacity of the lung for carbon monoxide (DLco) < 60% ro high molecular weight mucin-like antigen (KL-6) >1,000 U/ml; (14) more than 2 episodes of hemodynamically unstable sustained VT or VF per month before the ICD implantation; (15) are condidates for curative procedures for VT/VF such as catheter ablation or cryosurgery; (16) unstable angina pectoris; (17) DFT at the ICD implantation of more than 20 J; and (18) are pregnant (or have the possibility of), or are breast feeding.

Related Information

Contact

public contact
Name Hiroshi Furushima
Address 1-754 Asahimachi-dori Niigata City, Niigata, Japan Japan
Telephone 025-227-2185
E-mail niigata@niigata-u.ac.jp
Affiliation Niigata University School of Medicine First Department of Internal Medicine
scientific contact
Name Yoshifusa Aizawa
Address 1-754 Asahimachi-dori Niigata City, Niigata, Japan Japan
Telephone 025-227-2185
E-mail
Affiliation Niigata University School of Medicine First Department of Internal Medicine