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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040647
Receipt No. 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

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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
Email 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
Email roland-dyens@hotmail.co.jp

Sponsor
Institute Osaka General Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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