UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040227
Receipt number 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 21:54:25

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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 or person

Institute

Kumamoto univercity hospital

Institute

Department

Personal name



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

Value
https://center6.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