UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Nippon ICD Plus Pharmacologic Option Necessity
Title of the study (Brief title)	NIPPON study
Region	Japan

Condition
Condition	patients with spontaneous episode(s) of sustained ventricular tachycardia or ventricular fibrillation associated with organic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	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
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Amiodarone
Interventions/Control_2	ICD
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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) < 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.
Target sample size	400

Research contact person
Name of lead principal investigator	Yoshifusa Aizawa
Organization	Niigata University School of Medicine
Division name	First Department of Internal Medicine
Address	1-754 Asahimachi-dori Niigata City, Niigata, Japan
TEL	025-227-2185
Email

Public contact
Name of contact person	Hiroshi Furushima
Organization	Niigata University School of Medicine
Division name	First Department of Internal Medicine
Address	1-754 Asahimachi-dori Niigata City, Niigata, Japan
TEL	025-227-2185
Homepage URL
Email	niigata@niigata-u.ac.jp

Sponsor
Institute	NIPPON Investigators
Institute
Department

Funding Source
Organization	Japan Heart Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Cardiovascular Medicine, National Cardiovascular Center
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2006 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2006 Year 03 Month 01 Day
Anticipated trial start date	2006 Year 04 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2006 Year 03 Month 29 Day
Last modified on	2019 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000473