UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025296 |
|---|---|
| Receipt number | R000029096 |
| Scientific Title | Acute Heart Failure and Vascular Endothelial Glycocalyx Injury |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2025/12/22 09:23:49 |
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Basic information
Public title
Acute Heart Failure and Vascular Endothelial Glycocalyx Injury
Acronym
Vascular Endothelial Glycocalyx Injury in Heart Failure
Scientific Title
Acute Heart Failure and Vascular Endothelial Glycocalyx Injury
Scientific Title:Acronym
Vascular Endothelial Glycocalyx Injury in Heart Failure
Region
| Japan |
Condition
Condition
Acute Heart Failure
Classification by specialty
| Cardiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the relation between Glycocalyx injury and outcome of acute heart failure
Basic objectives2
Others
Basic objectives -Others
To confirm the relation between Glycocalyx injury and outcome of acute heart failure
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
prognosis and termination of the patients
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who admitted to Advanced Critical Care Center of our hospital due to acute heart failure
Key exclusion criteria
The patients who are Under 20 years-old
Target sample size
159
Research contact person
Name of lead principal investigator
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6448
hideshi@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6448
Homepage URL
hideshi@gifu-u.ac.jp
Sponsor or person
Institute
Advanced Critical Care Center, Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Advanced Critical Care Center, Gifu University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Heart Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University
Address
1-1 YANAGIDO, Gifu
Tel
0582306059
rinri@gifu-u.ac.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
| 2016 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0260350
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0260350
Number of participants that the trial has enrolled
159
Results
This study evaluated the prognostic value of serum syndecan-1 concentration at hospital admission in patients with heart failure. Serum syndecan-1 concentration was significantly associated with rehospitalization-free survival. Subsequently, syndecan-1 levels may have gradually decreased with treatment. Serum syndecan-1 levels may indicate endothelial glycocalyx damage and predict rehospitalization-free survival in heart failure patients.
Results date posted
| 2025 | Year | 12 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 152 patients (94 men, 58 women) were enrolled in this study, with a median age of 76 years (range: 68-85 years). These patients had underlying heart disease, and all were receiving some form of medication (including various combinations).
Participant flow
Patients who were hospitalized at Gifu Heart Center due to worsening heart failure between September 2017 and June 2018 were included in this study. Those who were <20 years old and/or had acute coronary syndrome, malignant tumor, liver cirrhosis, collagen disease, and hemodialysis were excluded from the analysis. Overall, 152 patients were enrolled in this study, and 784 samples were obtained.
Adverse events
None
Outcome measures
Demographic and clinical data (including medical history and medication history) were collected. The following data were included in the time-dependent Cox regression model: age, sex, serum albumin, AST, ALT, CK, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, BUN, Cre concentration, sodium, potassium, chloride, C-reactive protein, eGFR, white blood cell count, Hb concentration, Ht, HbA1c, LVDd, LVDs, IVST, PWT, LVEF, LAD, LAVI, IVC.
Serum syndecan-1 concentration was measured.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029096
