UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The interaction between gut microbiota and heart failure
Title of the study (Brief title)	Gut microbiota and heart failure
Region	Japan

Condition
Condition	Heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the composition of gut microbiota in patients with heart failure, compared with controls without heart failure
Basic objectives2	Others
Basic objectives -Others	To clarify the change of gut microbiota during therapy and association of gut microbiota with prognosis in patients with heart failure
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Gut microbiota
Key secondary outcomes	The metabolites of gut microbiota

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	Heart failure patients who were diagnosed by Framingham criteria Controls without heart failure who have hypertension, diabetes, or dyslipidemia
Key exclusion criteria	Patients with collagen disease, malignancy, bowel disease, or kidney disease
Target sample size	33

Research contact person
Name of lead principal investigator	Ken-ichi Hirata
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-5846
Email	hiratak@med.kobe-u.ac.jp

Public contact
Name of contact person	Tomoya Yamashita
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-5846
Homepage URL
Email	tomoya@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Depatment of Internal Medicine
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tokyo Institute of Technology
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 26 Day
Anticipated trial start date	2016 Year 10 Month 03 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	Cohort study

Management information
Registered date	2016 Year 05 Month 23 Day
Last modified on	2018 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025812