UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Clinical Significance of Serum Potassium levels in Patients with Heart Failure with Preserved Ejection Fraction
Title of the study (Brief title)	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	Kenichi Tsujita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
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	Taiki Nishihara
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033791