UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026209 |
|---|---|
| Receipt number | R000030106 |
| Scientific Title | Prospective investigation of the relationship between plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP) and pathology of patients with chronic heart failure |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/04/01 14:26:34 |
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Basic information
Public title
Prospective investigation of the relationship between plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP) and pathology of patients with chronic heart failure
Acronym
Prospective investigation of the relationship between plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP) and pathology of patients with chronic heart failure
Scientific Title
Prospective investigation of the relationship between plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP) and pathology of patients with chronic heart failure
Scientific Title:Acronym
Prospective investigation of the relationship between plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP) and pathology of patients with chronic heart failure
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP) and pathology of patients with chronic heart failure
Basic objectives2
Others
Basic objectives -Others
To make use of the results to the clinical medicine
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP)
Key secondary outcomes
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a)Patients whose main or deputy name of disease are chronic heart failure or healthy control group who are willing to take part in this study
(b)Age more than 20 years and under 85 years
(c)Patients or control group from whom a written informed consent was obtained
Key exclusion criteria
(a)Patients received investigational new drugs within six months
(b)Patients with non-cardiac or non-renal disease(such as a malignancy, serious infection, and so on) and their prognoses are less than one year
(c)Patients with renal insufficiency (eGFR< 30 ml/min/1.73m2) or on maintenance dialysis
(d)Patients who is not suitable to this study due to medical reasons
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norifumi Kawakita |
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
rm3ta6@bma.biglobe.ne.jp
Sponsor or person
Institute
Cardiovascular Medicine
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Medicine
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Based on the results, we'll also take the intervention test into account
Management information
Registered date
| 2017 | Year | 02 | Month | 18 | Day |
Last modified on
| 2017 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030106
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
