UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040647 |
|---|---|
| Receipt number | R000046394 |
| Scientific Title | Association Between Ghrelin and Butyrylcholinesterase in Patients With Acute Decompensated Heart Failure: A Cross-sectional Study |
| Date of disclosure of the study information | 2020/06/04 |
| Last modified on | 2020/06/04 13:24:44 |
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Basic information
Public title
Association Between Ghrelin and Butyrylcholinesterase in Patients With Acute Decompensated Heart Failure: A Cross-sectional Study
Acronym
Association Between Ghrelin and Butyrylcholinesterase in Patients With Acute Decompensated Heart Failure: A Cross-sectional Study
Scientific Title
Association Between Ghrelin and Butyrylcholinesterase in Patients With Acute Decompensated Heart Failure: A Cross-sectional Study
Scientific Title:Acronym
Association Between Ghrelin and Butyrylcholinesterase in Patients With Acute Decompensated Heart Failure: A Cross-sectional Study
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between plasma ghrelin level and serum butyrylcholinesterase level in patients with acute decompensated heart faiure.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between plasma ghrelin level and other factors which influences plasma ghrelin level.
To investigate the difference of plasma ghrelin level in various severity of heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between plasma ghrelin level and serum butyrylcholinesterase level
Key secondary outcomes
1) Vital signs: blood pressure, heart rate, body weight
2) Blood biomarkers: Albumin, prealbumin, T-chol, LDL-chol, HDL-chol, TG, BNP, NT-proBNP, hs-tropI, high sensitive CRP
3) Transthoracic echocardiography: LVEF, LVDd/Ds, E/e', LAD, LVEDV, LVESV, LV mass, TAPSE, RVEF, LA volume
4) Cardiac MIBG imaging: H/M MIBG uptake ratio on the delayed images, washout rate of cardiac MIBG
5) Body composition (bioimpedance method)
6) Electrocardiogram
7) Appetite score
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 who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
(The consent from their parents or legal guardians is needed for the patients with dementia.)
Key exclusion criteria
Patients with liver disorder
Patients with past history of removal of stomach
Patients who is taking rivastigmine or rikkunshito
Patients with anorexia or severe obesity (BMI>35)
Patients with endocrine disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Seo |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
kenkyusien@gh.opho.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Seo |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
558-0056
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
09036233037
Homepage URL
roland-dyens@hotmail.co.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka General Medical Center
Address
Mandaihigashi3-1-56,Sumiyosi-ku, Osaka
Tel
06-6692-1201
kenkyusien@gh.opho.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 | 06 | Month | 04 | 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 | 04 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2020 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046394
