UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research for detecting new surrogate marker of laboratory test or echocardiographic parameter in patients with acute decompensated heart failure: a retrospective observational study
Title of the study (Brief title)	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	Michio Shimabukuro
Organization	Tomishiro central hospital
Division name	Department of cardiology
Address	25 Ueta, Tomishiro-shi, Okinawa, Japan
TEL	098-850-3811
Email	mshimabukuro-ur@umin.ac.jp

Public contact
Name of contact person	Shimon Toma
Organization	Tomishiro central hospital
Division name	Clinical research assistant
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.internationaljournalofcardiology.com/article/S0167-5273(18)33131-0/abstract
Results	A concentric LV structure represented by a high RWT was associated with a poor prognosis in ADHF.
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