UMIN-CTR Clinical Trial

Basic information
Public title	The prognosis investigation of the patients with acute heart failure- by using various indicators-
Acronym	The prognosis investigation of the patients with acute heart failure- by using various indicators-
Scientific Title	The prognosis investigation of the patients with acute heart failure- by using various indicators-
Scientific Title:Acronym	The prognosis investigation of the patients with acute heart failure- by using various indicators-
Region	Japan

Condition
Condition	acute heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the patients with acute heart failure prospectively, clarify the actual situation, and evaluate the prognosis after hospital discharge pleiotropically
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Worsening of heart failure Hospitalization for severe arrhythmia Hospitalization for acute arteriosclerosis (acute coronary syndrome, cerebral infarction)
Key secondary outcomes	cardiovascular death (death from heart failure, sudden death, death from myocardial infarction/cerebral infarction)

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study (The consent from their parents or legal guardians is needed for the patients under 20 years or with dementia.)
Key exclusion criteria	Patients with diseases like malignancy which influence the prognosis except heart failure Patients who were judged inappropriate by the principal investigator
Target sample size	500

Research contact person
Last name of lead principal investigator	1st name Takahisa Middle name Last name Yamada
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Zip code	558-8558
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Email	kenkyusien@gh.opho.jp

Public contact
1st name of contact person	1st name Takahisa Middle name Last name Yamada
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Zip code	58-8558
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Homepage URL
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
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	Osaka General Medical Center
Address	Mandaihigashi3-1-56,Sumiyosi-ku, Osaka
Tel	06-6692-1201
Email	kenkyusien@gh.opho.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	大阪府立急性期・総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Enrolling by invitation
Date of protocol fixation	2011 Year 05 Month 20 Day
Date of IRB	2011 Year 06 Month 14 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective study

Management information
Registered date	2014 Year 09 Month 25 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017725