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
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
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
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
