UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective investigation of the relationship between plasma cardiac biomarkers(Neprilysin, pro BNP, ANP and BNP) and pathology of patients with chronic heart failure
Title of the study (Brief title)	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	Hiroshi Ito
Organization	Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name	Cardiovascular Medicine
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	Norifumi Kawakita
Organization	Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name	Cardiovascular Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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