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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022205
Receipt No. R000025578
Scientific Title The prognostic factor in heart failure patients
Date of disclosure of the study information 2016/05/05
Last modified on 2018/03/04

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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
Middle name
Last name Takahiro Komori
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL 0285-58-7344
Email tkomori@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Komori
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL 0285-58-7344
Homepage URL
Email tkomori@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine, Division of Cardiovascular Medicine, Department of Medicine
Institute
Department

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
Address
Tel
Email

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
2018 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025578

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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