UMIN-CTR Clinical Trial

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