UMIN-CTR Clinical Trial

Basic information
Public title	Clinical characteristics and outcome in patients with heart failure: multicenter, prospective, observational study
Acronym	Clinical characteristics and outcome in patients with heart failure
Scientific Title	Clinical characteristics and outcome in patients with heart failure: multicenter, prospective, observational study
Scientific Title:Acronym	Clinical characteristics and outcome in patients with heart failure
Region	Japan

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

Objectives
Narrative objectives1	To investigate the clinical characteristics and outcome in patients with heart failure
Basic objectives2	Others
Basic objectives -Others	To investigate the clinical characteristics and outcome in patients with heart failure
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hospitalization and death due to cardiovascular disease
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who were admitted in hospital due to heart failure
Key exclusion criteria	Exclusion criteria is age less than 20 years
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Mitsuru Middle name Last name Ohishi
Organization	Graduate school of medical and dental sciences, Kagoshima university
Division name	Cardiovascular medicine and hypertension
Zip code	890-8520
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
TEL	0992755318
Email	kubozono@cepp.ne.jp

Public contact
Name of contact person	1st name Takuro Middle name Last name Kubozono
Organization	Graduate school of medical and dental sciences, Kagoshima university
Division name	Cardiovascular medicine and hypertension
Zip code	890-8520
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
TEL	0992755318
Homepage URL
Email	kubozono@cepp.ne.jp

Sponsor
Institute	Graduate school of medical and dental sciences, Kagoshima university
Institute
Department

Funding Source
Organization	Graduate school of medical and dental sciences, Kagoshima 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	The Ethics Committee of Kagoshima University
Address	8-35-1, Sakuragaoka, Kagoshima, Japan
Tel	0992756692
Email	kufsyomu@kuas.kagoshima-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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially 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	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 01 Day
Date of IRB	2015 Year 10 Month 31 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2025 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The patients who were hospitalized to treat heart failure are enrolled in this study. The evaluation items in admission and at discharge of this study is as follows: 1. Cause of heart failure 2. Severity of heart failure 3. Treatment of acute phase and at discharge 4. Outcome at discharge We will investigate these evaluation items each year, and hospitalization and death for cardiovascular disease.

Management information
Registered date	2015 Year 11 Month 30 Day
Last modified on	2021 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018137