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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020003
Receipt No. R000018137
Scientific Title Clinical characteristics and outcome in patients with heart failure: multicenter, prospective, observational study
Date of disclosure of the study information 2015/11/30
Last modified on 2019/06/26

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Basic information
Public title Clinical characteristics and outcome in patients with heart failure: multicenter, prospective, observational study
Acronym Clinical characteristics and outcome in patients with heart failure
Scientific Title Clinical characteristics and outcome in patients with heart failure: multicenter, prospective, observational study
Scientific Title:Acronym Clinical characteristics and outcome in patients with heart failure
Region
Japan

Condition
Condition patients with heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical characteristics and outcome in patients with heart failure
Basic objectives2 Others
Basic objectives -Others To investigate the clinical characteristics and outcome in patients with heart failure
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hospitalization and death due to cardiovascular disease
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 The patients who were admitted in hospital due to heart failure
Key exclusion criteria Exclusion criteria is age less than 20 years
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Ohishi
Organization Graduate school of medical and dental sciences, Kagoshima university
Division name Cardiovascular medicine and hypertension
Zip code 890-8520
Address 8-35-1, Sakuragaoka, Kagoshima, Japan
TEL 0992755318
Email kubozono@cepp.ne.jp

Public contact
Name of contact person
1st name Takuro
Middle name
Last name Kubozono
Organization Graduate school of medical and dental sciences, Kagoshima university
Division name Cardiovascular medicine and hypertension
Zip code 890-8520
Address 8-35-1, Sakuragaoka, Kagoshima, Japan
TEL 0992755318
Homepage URL
Email kubozono@cepp.ne.jp

Sponsor
Institute Graduate school of medical and dental sciences, Kagoshima university
Institute
Department

Funding Source
Organization Graduate school of medical and dental sciences, Kagoshima university
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 The Ethics Committee of Kagoshima University
Address 8-35-1, Sakuragaoka, Kagoshima, Japan
Tel 0992756692
Email kufsyomu@kuas.kagoshima-u.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
2015 Year 11 Month 30 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 Open public recruiting
Date of protocol fixation
2014 Year 11 Month 01 Day
Date of IRB
2015 Year 10 Month 31 Day
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2025 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The patients who were hospitalized to treat heart failure are enrolled in this study. The evaluation items in admission and at discharge of this study is as follows:

1. Cause of heart failure
2. Severity of heart failure
3. Treatment of acute phase and at discharge
4. Outcome at discharge

We will investigate these evaluation items each year, and hospitalization and death for cardiovascular disease.

Management information
Registered date
2015 Year 11 Month 30 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018137

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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