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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Acute heart failure | |
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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.) |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Osaka General Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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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 |
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Date of disclosure of the study information |
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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 | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Other | |
Other related information | Cross-sectional study |
Management information | |||||||
Registered date |
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Last modified on |
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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 | |
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Research case data | |
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