UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on energy metabolism of heart failure patients
Acronym	Clinical study on energy metabolism of heart failure patients
Scientific Title	Clinical study on energy metabolism of heart failure patients
Scientific Title:Acronym	Clinical study on energy metabolism of heart failure patients
Region	Japan

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

Objectives
Narrative objectives1	We aim to establish nutritional therapy according to severity and cardiac function of heart failure patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between energy balance and cardiac function
Key secondary outcomes	1) Relationship between nutritional status at hospitalization and severity of heart failure 2) Relation between resting energy expenditure, consumption of carbohydrates and lipids and severity of heart failure 3) Relationship between muscle mass, body fat mass and severity of heart failure obtained by impedance method 4) Relationship between inflammatory cytokines, appetite regulators and the severity of heart failure

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	heart failure patients
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 admitted to cardiovascular internal medicine for the purpose of treating heart failure between August 2017 and March 2021 are targeted.
Key exclusion criteria	1) Minors 2) Patients with malignant tumor complications 3) Patients complicated with diseases affecting energy metabolism, such as chronic obstructive pulmonary disease, hyperthyroidism, hypothyroidism, severe infections 4) Patients wearing pacemaker 5) Others attending physician was deemed inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Sasaki
Organization	Shiga University Hospital
Division name	Division of Clinical Nutrition
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL	077-548-2518
Email	sasaki@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Shoko Middle name Last name Yasuhara
Organization	Shiga University Hospital
Division name	Division of Clinical Nutrition
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL	077-548-2518
Homepage URL
Email	yasu5288@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University Hospital
Institute
Department

Funding Source
Organization	None
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	Shiga University Hospital
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
Tel	077-548-2518
Email	yasu5288@belle.shiga-med.ac.jp

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

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2017 Year 08 Month 09 Day
Date of IRB	2017 Year 08 Month 09 Day
Anticipated trial start date	2017 Year 08 Month 10 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 04 Day
Last modified on	2022 Year 10 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031590