UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015755 |
|---|---|
| Receipt number | R000018336 |
| Scientific Title | Assessment of Cardiac Oxidative Metabolism, Sympathetic Innervation, and Function in Patients with Heart Failure |
| Date of disclosure of the study information | 2014/11/26 |
| Last modified on | 2014/11/26 10:23:30 |
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Basic information
Public title
Assessment of Cardiac Oxidative Metabolism, Sympathetic Innervation, and Function in Patients with Heart Failure
Acronym
Heart failure PET study
Scientific Title
Assessment of Cardiac Oxidative Metabolism, Sympathetic Innervation, and Function in Patients with Heart Failure
Scientific Title:Acronym
Heart failure PET study
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to characterize heart failure in view of cardiac oxidative metabolism, sympathetic innervation, and left ventricular function using imaging techniques such as PET.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
C-11 Acetate PET
C-11 Hydroxyephedrine
Echocardiographic measurements
Key secondary outcomes
Other imaging biomarkers such as Tc-99m MIBI or I-123 MIBG
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
C-11 Acetate PET
C-11 Hydroxyephedrine
Echocardiography
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. Coronary heart disease
2. Heart failure patients
Key exclusion criteria
1. Unstable angina or myocardial infarction at acute stage
2. Decompensated heart failure
3. Pregnant women
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Matsunari |
Organization
The Medical and Pharmacological Research Center Foundation
Division name
Clinical Research Department
Zip code
Address
Wo 32, Inoyama, Hakui-city, Ishikawa, 925-0613, Japan
TEL
0767-26-3311
matsunari@mprcf.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Kimura |
Organization
The Medical and Pharmacological Research Center Foundation
Division name
Administration
Zip code
Address
Wo 32, Inoyama, Hakui-city, Ishikawa, 925-0613, Japan
TEL
0767-26-3311
Homepage URL
soumu1@mprcf.or.jp
Sponsor or person
Institute
The Medical and Pharmacological Research Center Foundation
Institute
Department
Personal name
Funding Source
Organization
Ishikawa Prefectural Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
財団法人 先端医学薬学研究センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
| 2010 | Year | 02 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 26 | Day |
Last modified on
| 2014 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018336
