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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033755
Receipt No. R000038487
Scientific Title Exploratory research for detecting new surrogate marker of laboratory test or echocardiographic parameter in patients with acute decompensated heart failure: a retrospective observational study
Date of disclosure of the study information 2018/08/20
Last modified on 2018/08/14

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Basic information
Public title Exploratory research for detecting new surrogate marker of laboratory test or echocardiographic parameter in patients with acute decompensated heart failure: a retrospective observational study
Acronym Surrogate markers in patients with acute decompensated heart failure
Scientific Title Exploratory research for detecting new surrogate marker of laboratory test or echocardiographic parameter in patients with acute decompensated heart failure: a retrospective observational study
Scientific Title:Acronym Surrogate markers in patients with acute decompensated heart failure
Region
Japan

Condition
Condition Acute decompensated heart failure
Classification by specialty
Hepato-biliary-pancreatic medicine Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the new surrogate marker in patients with acute decompensated heart failure.
Basic objectives2 Others
Basic objectives -Others We aimed to investigate the prognostic value of echocardiographic markers or laboratory testing.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All-cause death
Key secondary outcomes Composite endpoint of all-cause death and heart failure re-hospitalization

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 Acute decompensated heart failure required for hospitalization
Key exclusion criteria Unperformed laboratory test or echocardiography during hospitalization
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Shimabukuro
Organization Tomishiro central hospital
Division name Department of cardiology
Zip code
Address 25 Ueta, Tomishiro-shi, Okinawa, Japan
TEL 098-850-3811
Email mshimabukuro-ur@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shimon Toma
Organization Tomishiro central hospital
Division name Clinical research assistant
Zip code
Address 25 Ueta, Tomishiro-shi, Okinawa, Japan
TEL 098-850-3811
Homepage URL https://tomishiro-chp.jp/clinical-trial/
Email toma.tomishiro.hp@gmail.com

Sponsor
Institute Tomishiro central hospital
Department of cardiology
Institute
Department

Funding Source
Organization Self funding
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
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 豊見城中央病院

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.internationaljournalofcardiology.com/article/S0167-5273(18)33131-0/abstract
Number of participants that the trial has enrolled
Results
A concentric LV structure represented by a high RWT was associated with a poor prognosis in ADHF.
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
2013 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2016 Year 10 Month 30 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
2017 Year 01 Month 15 Day
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information The lack of association between LVM/LVEDV and mortality may result from methodological issues.

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2018 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038487

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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