UMIN-CTR Clinical Trial

Basic information
Public title	The prognostic factor in heart failure patients
Acronym	Prognostic factor in heart failure
Scientific Title	The prognostic factor in heart failure patients
Scientific Title:Acronym	Prognostic factor in heart failure
Region	Japan

Condition
Condition	Heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of prognostic factor in heart failure patients
Basic objectives2	Others
Basic objectives -Others	Observational study in heart failure patients and investigation of prognostic factor
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cardiovascular events
Key secondary outcomes	All-cause death

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hospitalized heart failure patients
Key exclusion criteria	patients with documented dementia, delirium, infections, depression during treatment, renal failure (serum creatinine >3 mg/dl), cancer, other severe non-cardiovascular diseases, or pacemaker or implantable cardioverter defibrillator implantation.
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Komori
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Medicine
Zip code	329-0498
Address	3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL	0285-58-7344
Email	tkomori@jichi.ac.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Komori
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Medicine
Zip code	329-0498
Address	3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL	0285-58-7344
Homepage URL
Email	tkomori@jichi.ac.jp

Sponsor
Institute	Jichi Medical University School of Medicine, Division of Cardiovascular Medicine, Department of Medicine
Institute
Department

Funding Source
Organization	None
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	Jichi Medical University School of Medicine
Address	3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
Tel	0285-44-2111
Email	rksc_monitor@jichi.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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 05 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/circj/81/2/81_CJ-16-0740/_article
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	No longer recruiting
Date of protocol fixation	2007 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2007 Year 11 Month 12 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2026 Year 09 Month 30 Day

Other
Other related information	The patients is followed-up for 3 years.

Management information
Registered date	2016 Year 05 Month 05 Day
Last modified on	2021 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025578