UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004027 |
|---|---|
| Receipt number | R000004844 |
| Scientific Title | A retrospective multicenter study of patients with acute heart failure in the Tohoku district |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2012/08/17 17:28:56 |
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Basic information
Public title
A retrospective multicenter study of patients with acute heart failure in the Tohoku district
Acronym
Acute heart failure in the Tohoku district
Scientific Title
A retrospective multicenter study of patients with acute heart failure in the Tohoku district
Scientific Title:Acronym
Acute heart failure in the Tohoku district
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prevalence of acute heart failure (AHF) is expected to increase in Japan. Widespread use of RAS inhibitors and beta adrenergic blocking agents have improved the prognosis of patients with heart failure (HF), but HF remains a progressive disease suddenly causing decompensation and have poor prognosis. Hemodynamic diterioration in AHF patients frequently appears acutely, so the management of AHF should be performed rapidly. But, because there are little evidence-based data about AHF treatment, most of the management of AHF is usually guided by personal experience. The aim of this study is to clarify the overall clinical characteristics and prognostic factor of patients with AHF in Miyagi and Iwate prefectures.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to clarify the overall clinical characteristics and prognostic factor of patients with AHF
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
Readmission for worsening heart failure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive AHF cases who met the Framingham criteria and were admitted from 2006 to 2008 are eligible for this study.
Key exclusion criteria
Patients aged <20 years and patients who were not considered suitable by the attending physicians are excluded.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shiba |
Organization
Department of Evidence-Based Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryocho, Aoba-ku, Sendai, Japan 980-8574
TEL
022-717-7156
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanobu Miura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryocho, Aoba-ku, Sendai, Japan 980-8574
TEL
022-717-7156
Homepage URL
masa-miura@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
The Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Pfizer health research foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学附属病院、岩手県立中央病院、大崎市民病院、みやぎ県南中核病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective multicenter cohort study.
Management information
Registered date
| 2010 | Year | 08 | Month | 10 | Day |
Last modified on
| 2012 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004844
