UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000381 |
|---|---|
| Receipt number | R000000473 |
| Scientific Title | Nippon ICD Plus Pharmacologic Option Necessity |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2019/01/31 17:26:32 |
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Basic information
Public title
Nippon ICD Plus Pharmacologic Option Necessity
Acronym
NIPPON study
Scientific Title
Nippon ICD Plus Pharmacologic Option Necessity
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshifusa Aizawa |
Organization
Niigata University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
1-754 Asahimachi-dori Niigata City, Niigata, Japan
TEL
025-227-2185
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Furushima |
Organization
Niigata University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
1-754 Asahimachi-dori Niigata City, Niigata, Japan
TEL
025-227-2185
Homepage URL
niigata@niigata-u.ac.jp
Sponsor or person
Institute
NIPPON Investigators
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000473
