UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020003 |
|---|---|
| Receipt number | 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 | 2021/12/04 11:28:10 |
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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
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
kubozono@cepp.ne.jp
Sponsor or person
Institute
Graduate school of medical and dental sciences, Kagoshima university
Institute
Department
Personal name
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
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
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
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
| 2021 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018137
| 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 |
