UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on nutritional matabolism and intestinal flora in patients with heart failure
Acronym	Clinical study on nutritional matabolism and intestinal flora in patients with heart failure
Scientific Title	Clinical study on nutritional matabolism and intestinal flora in patients with heart failure
Scientific Title:Acronym	Clinical study on nutritional matabolism and intestinal flora 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	We will analyze the intestinal flora of patients with heart failure, confirm the severity of heart failure and the disorder of the intestinal flora, and clarify the involvement of cardiointestinal correlation in the nutritional metabolism pathology of heart failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between heart failure severity and gut flora, short-chain fatty acid levels
Key secondary outcomes	1) Relationship between the severity of heart failure and endotoxin and procalcitonin concentrations 2) Relationship between muscle mass and body fat mass and intestinal flora and short-chain fatty acid concentration 3) Relationship between inflammatory cytokines and endotoxin, procalcitonin, and gut flora 4) Relationship between nutritional indicators at admission and inflammatory cytokines 5) Relationship between nutritional index at admission and endotoxin concentration 6) Relationship between nutritional index at admission, intestinal flora, and short-chain fatty acid concentration

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing inpatient treatment at the Department of Cardiology, Shiga University of Medical Science Hospital during the research period
Key exclusion criteria	1) Those who do not agree 2) Minors 3) Patients with malignant tumor complications. If a malignant tumor is found after participating in the study, it will be excluded from the analysis. 4) Patients with chronic obstructive pulmonary disease, hyperthyroidism, hypothyroidism, serious infectious diseases, and other diseases that affect nutritional metabolism. 5) Patients with pacemakers 6) Patients being treated with antibiotics 7) Other patients that the doctor in charge deems inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Sasaki
Organization	Shiga University of Medical Science Hospital
Division name	Division of Clinical Nutrition
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL	077-548-2519
Email	sasaki@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Sasaki
Organization	Shiga University of Medical Science Hospital
Division name	Division of Clinical Nutrition
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL	077-548-2519
Homepage URL
Email	sasaki@belle.shiga-med.ac.jp

Sponsor
Institute	Division of Clinical Nutrition , Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Clinical Nutrition , Shiga University of Medical Science Hospital
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
Tel	077-548-2519
Email	sasaki@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	2020 Year 11 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 06 Month 24 Day
Date of IRB	2020 Year 07 Month 27 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1) Relationship between the severity of heart failure and endotoxin and procalcitonin concentrations 2) Relationship between muscle mass and body fat mass and intestinal flora and short-chain fatty acid concentration 3) Relationship between inflammatory cytokines and endotoxin, procalcitonin, and gut flora 4) Relationship between nutritional indicators at admission and inflammatory cytokines 5) Relationship between nutritional index at admission and endotoxin concentration 6) Relationship between nutritional index at admission, intestinal flora, and short-chain fatty acid concentration

Management information
Registered date	2020 Year 10 Month 08 Day
Last modified on	2021 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047954