UMIN-CTR Clinical Trial

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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