UMIN-CTR Clinical Trial

Basic information
Public title	The clinical significance of serum magnesium levels in patients with heart failure with preserved ejection fraction
Acronym	Heart failure with preserved ejection fraction and serum magnesium
Scientific Title	The clinical significance of serum magnesium levels in patients with heart failure with preserved ejection fraction
Scientific Title:Acronym	Heart failure with preserved ejection fraction and serum magnesium
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 magnesium levels and other biomarker of heart failure in patient with heart failure with preserved ejection fraction and to investigate the prognostic involvement of serum magnesium 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 anginapectoris, 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 Kenichi Middle name Last name Tsujita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-5886
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 Taiki Middle name Last name Nishihara
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-5886
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	Graduate School of Medical Sciences, Kumamoto University
Address	1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
Tel	81-96-373-5657
Email	ski-shien@jimu.kumamoto-u.ac.jp

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	2018 Year 04 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	Medicine (Baltimore). 2019 Sep;98(38):e17069. doi: 10.1097/MD.0000000000017069.
Number of participants that the trial has enrolled	452
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	2017 Year 09 Month 19 Day
Anticipated trial start date	2008 Year 01 Month 20 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 04 Month 23 Day
Last modified on	2020 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036884