UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002253 |
|---|---|
| Receipt number | R000002371 |
| Scientific Title | Acute Decompensated Heart Failure in Tottori University Hospital |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2022/08/10 09:33:57 |
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Basic information
Public title
Acute Decompensated Heart Failure in Tottori University Hospital
Acronym
Acute Decompensated Heart Failure in Tottori University Hospital
Scientific Title
Acute Decompensated Heart Failure in Tottori University Hospital
Scientific Title:Acronym
Acute Decompensated Heart Failure in Tottori University Hospital
Region
| Japan |
Condition
Condition
The patients hospitalized with acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the background and to survey the present therapeutic strategy of acute decompensated heart failure.
Basic objectives2
Others
Basic objectives -Others
To clarify the association between dementia, undernutrition, home environment and prognosis in elderly patients with heart failure .
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in-hospital mortality, two year mortality and rehospitalization
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 hospitalized with acute decompensated heart failure
Key exclusion criteria
under 20 years old, the patients diagnosed as acute coronary syndrome, the patients who judged doctor was inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Kato |
Organization
Tottori University
Division name
Department of Cardiovascular Medicine, Faculty of Medicine
Zip code
6838504
Address
36-1 Nishichou, Yonago, Tottori
TEL
0859-38-6517
mkato@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Kato |
Organization
Tottori University
Division name
Department of Cardiovascular Medicine, Faculty of Medicine
Zip code
683-8504
Address
36-1 Nishichou, Yonago, Tottori
TEL
0859-38-6517
Homepage URL
mkato@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
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
Tottori University
Address
36-1 Nishichou Yonago Tottori, Japan
Tel
0859-38-7110
me-kenkyu@adm.tottori-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
| 2009 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
349
Results
Five independent prognostic factors were identified by multivariate logistic regression analysis, and each factor was assigned a number of points proportional to its regression
coefficient: prior heart failure hospitalization (2 points), sodium lower than138mmol/L (2 points), BUN greater than 35mg/dl(2 points), albumin lower than 3.2g/dl (3 points), and BNP greater than 980 pg/ml (2 points); in particular, hypoalbuminemia was
identified as the strongest prognostic factor.
Results date posted
| 2022 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The present study enrolled 349 patients aged over 65 years who were hospitalized with
ADHF from January 2004 to October 2008.
Participant flow
The present study enrolled 349 patients aged over 65 years who were hospitalized with
ADHF from January 2004 to October 2008.
Adverse events
None
Outcome measures
In hospital death
An independent clinical indices to predict
in-hospital death
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) The accumulation of the condition of a patient, epidemiologic data about the patient background: Age, sex, back ground, symptom, vital signs, having atrial fibrillation, renal dysfunction or not,constract or diastolic dysfunction (2) The present conditions of the cure: medical therapy on the discharge, invasive cure(3) A short and middle term prognosis : rate of inhospilat moetality and rate of rehospitalization after discharge (for 180 days)
Management information
Registered date
| 2009 | Year | 07 | Month | 27 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002371
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