patients with spontaneous episode(s) of sustained ventricular tachycardia or ventricular fibrillation associated with organic heart disease
Conditions
Interventions
Amiodarone
ICD
Sponsors
NIPPON Investigators
Department of Cardiovascular Medicine, National Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients entering this trial will meet the following entry criteria: (1) all patients will have spontaneous episode(s) of sustained VT or VF; (2) all patients will have organic heart disease as documented either by electrocardiography, echocardiography, cardiac catherterization, nuclear scintigraphy, computed tomography or magnetic resonance imaging; (3) all patients will correspond to the guidelines for ICD therapy determined by the Ministry of Health, Labor and Welfare, in Japan; (4) all patients will be free of any class I or class III drugs at the time of the ICD implantation, and all anti-arrhythmic srugs (except for beta-blockers) will be discontinued at least 5 half-lives before implantation. Beta-blockers will be allowed to be prescribed when appropriate.
Exclusion criteria
Exclusion 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Furushima
Niigata University School of Medicine First Department of Internal Medicine
Outcome results
None listed