UMIN-CTR Clinical Trial

Basic information
Public title	Acute Decompensated Heart Failure in Tottori University Hospital
Acronym	Acute Decompensated Heart Failure in Tottori University Hospital
Scientific Title	Acute Decompensated Heart Failure in Tottori University Hospital
Scientific Title:Acronym	Acute Decompensated Heart Failure in Tottori University Hospital
Region	Japan

Condition
Condition	The patients hospitalized with acute decompensated heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the background and to survey the present therapeutic strategy of acute decompensated heart failure.
Basic objectives2	Others
Basic objectives -Others	To clarify the association between dementia, undernutrition, home environment and prognosis in elderly patients with heart failure .
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	in-hospital mortality, two year mortality and rehospitalization
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 hospitalized with acute decompensated heart failure
Key exclusion criteria	under 20 years old, the patients diagnosed as acute coronary syndrome, the patients who judged doctor was inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Kato
Organization	Tottori University
Division name	Department of Cardiovascular Medicine, Faculty of Medicine
Zip code	6838504
Address	36-1 Nishichou, Yonago, Tottori
TEL	0859-38-6517
Email	mkato@tottori-u.ac.jp

Public contact
Name of contact person	1st name Masahiko Middle name Last name Kato
Organization	Tottori University
Division name	Department of Cardiovascular Medicine, Faculty of Medicine
Zip code	683-8504
Address	36-1 Nishichou, Yonago, Tottori
TEL	0859-38-6517
Homepage URL
Email	mkato@tottori-u.ac.jp

Sponsor
Institute	Tottori University
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	Tottori University
Address	36-1 Nishichou Yonago Tottori, Japan
Tel	0859-38-7110
Email	me-kenkyu@adm.tottori-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	2009 Year 08 Month 01 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	349
Results	Five independent prognostic factors were identified by multivariate logistic regression analysis, and each factor was assigned a number of points proportional to its regression coefficient: prior heart failure hospitalization (2 points), sodium lower than138mmol/L (2 points), BUN greater than 35mg/dl(2 points), albumin lower than 3.2g/dl (3 points), and BNP greater than 980 pg/ml (2 points); in particular, hypoalbuminemia was identified as the strongest prognostic factor.
Results date posted	2022 Year 08 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The present study enrolled 349 patients aged over 65 years who were hospitalized with ADHF from January 2004 to October 2008.
Participant flow	The present study enrolled 349 patients aged over 65 years who were hospitalized with ADHF from January 2004 to October 2008.
Adverse events	None
Outcome measures	In hospital death An independent clinical indices to predict in-hospital death
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2009 Year 04 Month 01 Day
Date of IRB	2009 Year 05 Month 01 Day
Anticipated trial start date	2009 Year 05 Month 01 Day
Last follow-up date	2012 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(1) The accumulation of the condition of a patient, epidemiologic data about the patient background: Age, sex, back ground, symptom, vital signs, having atrial fibrillation, renal dysfunction or not,constract or diastolic dysfunction (2) The present conditions of the cure: medical therapy on the discharge, invasive cure(3) A short and middle term prognosis : rate of inhospilat moetality and rate of rehospitalization after discharge (for 180 days)

Management information
Registered date	2009 Year 07 Month 27 Day
Last modified on	2022 Year 08 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002371