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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014811
Receipt No. R000017220
Scientific Title Prognostic Value of Plasma Galectin-3 Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Date of disclosure of the study information 2014/08/10
Last modified on 2014/08/10

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Basic information
Public title Prognostic Value of Plasma Galectin-3 Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Acronym Prognostic Value of Plasma Galectin-3 Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Scientific Title Prognostic Value of Plasma Galectin-3 Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Scientific Title:Acronym Prognostic Value of Plasma Galectin-3 Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Region
Japan

Condition
Condition Heart failure with normal left ventricular ejection fraction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Prognostic Value of Plasma Galectin-3 Concentrations for Cardiovascular Events in Patients with Heart Failure with Normal Left Ventricular Ejection Fraction
Basic objectives2 Others
Basic objectives -Others prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CV death, non-fatal myocardial infarction or ischemic stroke, unstable angina pectoris, hospitalization for HF, or coronary revascularization
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
100 years-old >
Gender Male and Female
Key inclusion criteria a presence of HF symptoms
2 LVEF>50%
3 E/e'>15,or 8<E/e'<15 and BNP>200
Key exclusion criteria Severe valvular heart disease
Chronic renal failure requiring hemodialysis
Active systemic inflammatory disease
Severe collagen disease
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Kumamoto University Graduate School of Medical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo,Kumamotoshichuo-ku,Kumamoto-ken JAPAN
TEL 096-373-5175
Email ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Kusaka
Organization Kumamoto University Graduate School of Medical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo,Kumamotoshichuo-ku,Kumamoto-ken JAPAN
TEL 096-373-5175
Homepage URL
Email kusaka@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Kumamoto University Graduate School of Medical Sciences ,Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization
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
2014 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2006 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information HFNEF patients were followed prospectively every month at the outpatient clinic until July 2012 or until an endpoint occurred.

Management information
Registered date
2014 Year 08 Month 10 Day
Last modified on
2014 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017220

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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