UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022414
Receipt number R000025812
Scientific Title The interaction between gut microbiota and heart failure
Date of disclosure of the study information 2016/05/23
Last modified on 2018/04/13 19:39:04

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Basic information

Public title

The interaction between gut microbiota and heart failure

Acronym

Gut microbiota and heart failure

Scientific Title

The interaction between gut microbiota and heart failure

Scientific Title:Acronym

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

1st name
Middle name
Last name Ken-ichi Hirata

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code


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

1st name
Middle name
Last name Tomoya Yamashita

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code


Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-5846

Homepage URL


Email

tomoya@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Depatment of Internal Medicine

Institute

Department

Personal name



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


IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Open public recruiting

Date of protocol fixation

2016 Year 04 Month 26 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025812


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name