UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022205 |
|---|---|
| Receipt number | R000025578 |
| Scientific Title | The prognostic factor in heart failure patients |
| Date of disclosure of the study information | 2016/05/05 |
| Last modified on | 2021/11/08 09:56:52 |
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Basic information
Public title
The prognostic factor in heart failure patients
Acronym
Prognostic factor in heart failure
Scientific Title
The prognostic factor in heart failure patients
Scientific Title:Acronym
Prognostic factor in heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of prognostic factor in heart failure patients
Basic objectives2
Others
Basic objectives -Others
Observational study in heart failure patients and investigation of prognostic factor
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular events
Key secondary outcomes
All-cause death
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized heart failure patients
Key exclusion criteria
patients with documented dementia, delirium, infections, depression during treatment, renal failure (serum creatinine >3 mg/dl), cancer, other severe non-cardiovascular diseases, or pacemaker or implantable cardioverter defibrillator implantation.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Komori |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL
0285-58-7344
tkomori@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Komori |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL
0285-58-7344
Homepage URL
tkomori@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine, Division of Cardiovascular Medicine, Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Jichi Medical University School of Medicine
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
Tel
0285-44-2111
rksc_monitor@jichi.ac.jp
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
| 2016 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/81/2/81_CJ-16-0740/_article
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 | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 09 | Month | 30 | Day |
Other
Other related information
The patients is followed-up for 3 years.
Management information
Registered date
| 2016 | Year | 05 | Month | 05 | Day |
Last modified on
| 2021 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025578
