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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029600
Receipt No. R000033791
Scientific Title The Clinical Significance of Serum Potassium levels in Patients with Heart Failure with Preserved Ejection Fraction
Date of disclosure of the study information 2017/10/18
Last modified on 2018/10/18

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Basic information
Public title The Clinical Significance of Serum Potassium levels in Patients with Heart Failure with Preserved Ejection Fraction
Acronym Heart failure with preserved ejection fraction and serum potassium
Scientific Title The Clinical Significance of Serum Potassium levels in Patients with Heart Failure with Preserved Ejection Fraction
Scientific Title:Acronym Heart failure with preserved ejection fraction and serum potassium
Region
Japan

Condition
Condition Heart failure with preserved ejection fraction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between serum potassium levels and other biomarker of heart failure in patient with heart failure with preserved ejection fraction and to investigate the prognostic involvement of serum potassium levels in the future cardiovascular events in patients with heart failure with preserved ejection fraction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal stroke, or re-hospitalization for heart failure
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
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with heart failure who were hospitalized in Kumamoto University Hospital
Key exclusion criteria Do not meet diagnostic criteria for heart failure with preserved ejection fraction
Severe valvular disease
Active infection diseases
End stage of chronic kidney diseases
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Tsujita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL 81-96-373-5175
Email cvmhisho@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiki Nishihara
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL 81-96-373-5175
Homepage URL
Email t-nishi@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
Organization
Division
Category of Funding Organization Self funding
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 熊本大学病院(熊本県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results 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 Main results already published
Date of protocol fixation
2008 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients were followed every month at the outpatient clinic until December 2013 or until an endpoint occured.

Management information
Registered date
2017 Year 10 Month 17 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033791

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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