UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023440
Receipt No. R000026993
Scientific Title Evaluation of the impact of blood urea nitrogen kinetics during hospitalization on long-term prognosis in acute heart failure patients
Date of disclosure of the study information 2016/08/02
Last modified on 2016/08/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the impact of blood urea nitrogen kinetics during hospitalization on long-term prognosis in acute heart failure patients
Acronym BUN kinetics on long-term prognosis in AHF patients
Scientific Title Evaluation of the impact of blood urea nitrogen kinetics during hospitalization on long-term prognosis in acute heart failure patients
Scientific Title:Acronym BUN kinetics on long-term prognosis in AHF patients
Region
Japan

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

Objectives
Narrative objectives1 To estimate the impact of changes in BUN level during hospitalization on long-term prognosis in acute heart failure patients.
Basic objectives2 Others
Basic objectives -Others To compare clinical profiles and all-cause and cardiovascular mortality among patients stratified with BUN at admission and discharge.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiovascular mortality
Key secondary outcomes All-cause mortality

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 Consecutive patients who were urgently hospitalized due to acutely decompensation of chronic heart failure or acute heart failure in a single cardiovascular center.
Key exclusion criteria Patients with regular hemodialysis.
Patients without available data of BUN either at admission or discharge.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhisa Hagiwara
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL 81333538111
Email mhagi@hij.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Tokyo Women's Medial University
Division name Cardiology
Zip code
Address Kawadacho 8-1, Shinjuku-ku, Tokyo
TEL 81333538111
Homepage URL
Email juken1123@hotmail.co.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical 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
Address
Tel
Email

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 08 Month 02 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 Completed
Date of protocol fixation
2013 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Median follow-up duration was 298 days in patients who discharged alive from hospital and had available data of BUN at discharge.

Management information
Registered date
2016 Year 08 Month 02 Day
Last modified on
2016 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026993

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.