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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040227
Receipt No. R000045891
Scientific Title Prognostic significance of liver stiffness assessed by Fibrosis-4 index in patients with heart failure
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/23

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Basic information
Public title Prognostic significance of liver stiffness assessed by Fibrosis-4 index in patients with heart failure
Acronym Prognosis of chronic heart failure and FIB4 index
Scientific Title Prognostic significance of liver stiffness assessed by Fibrosis-4 index in patients with heart failure
Scientific Title:Acronym Prognosis of chronic heart failure and FIB4 index
Region
Japan

Condition
Condition Patients of chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Heart failure (HF) related congestive hepatopathy has been a well-recognized problem in management of HF. The Fibrosis-4 (FIB4) index calculated by (age * aspartate aminotransferase (IU/L)/platelet count (10 9/L) * square root of alanine aminotransferase (IU/L)) is useful for evaluating liver stiffness. We aimed to investigate the impact of the FIB4 index on prognosis in patients with HF.
Basic objectives2 Others
Basic objectives -Others Heart failure (HF) related congestive hepatopathy has been a well-recognized problem in management of HF. The Fibrosis-4 (FIB4) index calculated by (age * aspartate aminotransferase (IU/L)/platelet count (10 9/L) * square root of alanine aminotransferase (IU/L)) is useful for evaluating liver stiffness. We aimed to investigate the impact of the FIB4 index on prognosis in patients with HF.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Consecutive HF patients referred for hospitalization at Kumamoto University Hospital were registered between 2006 and 2015. We observed cardiovascular outcomes in each type of HF (HF with reduced left ventricular ejection fraction (LVEF) (HFrEF), HF with mid-range LVEF (HFmrEF) and with preserved LVEF (HFpEF)) according to their FIB4 index; group 1 (FIB4 index <1.3), group 2 (FIB4 index: 1.3-2.67) and group 3 (FIB4 index >2.67).
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive HF patients referred for hospitalization at Kumamoto University Hospital between 2006 and 2015 were registered.
Key exclusion criteria Patients were excluded for the following reasons: liver disease, severe valvular disease, active infective diseases, history of malignancy, and end stage of renal disease (estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73m).
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Tsujita
Organization Kumamoto univercity hospital
Division name cardiology
Zip code 860-8556
Address 1-1-1 Honjo Tyuouku Kumamotoshi
TEL 0963735175
Email tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Masafumi
Middle name
Last name Takae
Organization Kumamoto univercity hospital
Division name cardiology
Zip code 860-8556
Address 1-1-1 Honjo Tyuouku Kumamotoshi
TEL 0963735175
Homepage URL
Email qqcv2t3d@yahoo.co.jp

Sponsor
Institute Kumamoto univercity hospital
Institute
Department

Funding Source
Organization Kumamoto univercity hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto univercity hospital
Address 1-1-1 Honjo Tyuouku Kumamotoshi
Tel 0963735175
Email qqcv2t3d@yahoo.co.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
2020 Year 05 Month 01 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 704
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
2006 Year 04 Month 01 Day
Date of IRB
2017 Year 04 Month 01 Day
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 04 Month 23 Day
Last modified on
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045891

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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