Nippon ICD Plus Pharmacologic Option Necessity

UMIN ID: C000000381

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: patients with spontaneous episode(s) of sustained ventricular tachycardia or ventricular fibrillation associated with organic heart disease
• Date of first enrollment: 2006/04/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Amiodarone
ICD

Outcome(s)

• Primary Outcome: Primary 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 Outcome: Secondary 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 minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The 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

• Primary Sponsor: NIPPON Investigators
• Secondary Sponsor: Department of Cardiovascular Medicine, National Cardiovascular Center
• Source(s) of Monetary Support: Japan Heart Foundation