UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042054
Receipt number R000047954
Scientific Title Clinical study on nutritional matabolism and intestinal flora in patients with heart failure
Date of disclosure of the study information 2020/11/01
Last modified on 2021/10/15 16:04:52

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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 or person

Institute

Division of Clinical Nutrition , Shiga University of Medical Science Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name