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
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
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
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
