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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026209
Receipt No. 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

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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
Email 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
Email rm3ta6@bma.biglobe.ne.jp

Sponsor
Institute Cardiovascular Medicine
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030106

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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