UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000626 |
|---|---|
| Receipt number | R000000756 |
| Scientific Title | Prognostic Value of Cardiac 123I-Metaiodobenzylguanidine Imaging in Patients With Stabilized Chronic Heart Failure and Reduced Left Ventricular Ejection Fraction |
| Date of disclosure of the study information | 2007/03/03 |
| Last modified on | 2007/03/01 15:41:03 |
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Basic information
Public title
Prognostic Value of Cardiac 123I-Metaiodobenzylguanidine Imaging in Patients With Stabilized Chronic Heart Failure and Reduced Left Ventricular Ejection Fraction
Acronym
Prognostic Value of 123I-MIBG in CHF
Scientific Title
Prognostic Value of Cardiac 123I-Metaiodobenzylguanidine Imaging in Patients With Stabilized Chronic Heart Failure and Reduced Left Ventricular Ejection Fraction
Scientific Title:Acronym
Prognostic Value of 123I-MIBG in CHF
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigated the usefulness of 123I-metaiodobenzylguanidine (MIBG) scintigraphy in the evaluation of long-term prognosis in stabilized patients with chronic heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Fatal cardiac events during the study.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1)Definitive signs and symptoms of decompensated acute heart failure and required hospitalization
2)Left ventricular ejection fraction (LVEF) of less than 45%
3)No cardiac events for at least 5 months after hospital discharge
4)Fully informed consent was obtained
Key exclusion criteria
1)Congenital heart disease
2)Unstable angina
3)Acute myocardial infarction
4)Hepatic failure
5)Renal failure
6)Active cancer
7)Severe heart failure requiring mechanical support (intraaortic balloon pumping, left ventricular assist device, or cardiac resynchronization therapy)
8)Requiring heart transplantation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Ichikawa |
Organization
Kitakanto Cardiovascular Hospital
Division name
Internal Medicine
Zip code
Address
740 Shimohakoda, Hokkitsu-machi, Shibukawa, Gunma, Japan
TEL
027-232-7111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shu Kasama |
Organization
Kitakanto Cardiovascular Hospital
Division name
Internal Medicine
Zip code
Address
740 Shimohakoda, Hokkitsu-machi, Shibukawa, Gunma, Japan
TEL
027-232-7111
Homepage URL
s-kasama@bay.wind.ne.jp
Sponsor or person
Institute
Kitakanto Cardiovascular Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitakanto Cardiovascular Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2007 | Year | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 1999 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 1999 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 03 | Month | 01 | Day |
Other
Other related information
Influence of MIBG scintigraphic parameters on cumulative survival, prospective study
Management information
Registered date
| 2007 | Year | 03 | Month | 01 | Day |
Last modified on
| 2007 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
