UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of extracellular water-to-total body water ratio using bioelectrical impedance analysis in patients with heart failure
Title of the study (Brief title)	Extracellular water-to-total body water ratio in patients with heart failure
Region	Japan

Condition
Condition	Heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of the measurement of body composition and edema status based on extracellular water (ECW)-to-total body water (TBW) ratio using bioelectrical impedance analysis (BIA) for estimating heart failure status, efficacy of treatment and predicting outcome in patients with heart failure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between rate of change in ECW/TBW ratio and conventional parameters (body weight, echographic parameters and BNP or NT-proBNP values) at acute and chronic phase
Key secondary outcomes	Relationship of stable-phase ECW/TBW ratio or rate of change in ECW/TBW ratio and all cause death and major adverse outcomes (cardiovascular death and heart failure-related re-admission)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Measurement of extracellular water (ECW)-to-total body water (TBW) ratio using bioelectrical impedance analysis (BIA) and conventional parameters (body weight, echographic parameters and BNP or NT-proBNP values) at acute and chronic phase in hospitalized patients with heart failure
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	Patients required hospitalization due to heart failure
Key exclusion criteria	1. Patients with pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devise 2. Inadequate patients by physician's discresion
Target sample size	200

Research contact person
Name of lead principal investigator	Kei Yunoki
Organization	Tsuyama Chuo Hospital
Division name	Department of Cardiology
Address	1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL	0868-21-8111
Email	kei.yunoki@gmail.com

Public contact
Name of contact person	Yusuke Nanba
Organization	Tsuyama Chuo Hospital
Division name	Department of Cardiology
Address	1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL	0868-21-8111
Homepage URL	http://www.tch.or.jp/clinical_research.html
Email	d5w8y.nmb@gmail.com

Sponsor
Institute	Department of Cardiology, Tsuyama Chuo Hospital
Institute
Department

Funding Source
Organization	Tsuyama Chuo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	津山中央病院（岡山県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 05 Day
Last modified on	2017 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034566