UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033755
Receipt number 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 07:25:21

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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 or person

Institute

Tomishiro central hospital
Department of cardiology

Institute

Department

Personal name



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

Value
https://center6.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