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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004027
Receipt No. 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

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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
Email

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
Email masa-miura@cardio.med.tohoku.ac.jp

Sponsor
Institute The Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004844

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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