UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002170 |
|---|---|
| Receipt number | R000002665 |
| Scientific Title | The Clinical Significance of Plasma Pentraxin 3 levels for Patients with Diastolic Heart Failure |
| Date of disclosure of the study information | 2009/07/08 |
| Last modified on | 2013/10/07 08:44:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Clinical Significance of Plasma Pentraxin 3 levels for Patients with Diastolic Heart Failure
Acronym
Pentaraxin 3 in Left Ventricular Diastolic Dysfunction
Scientific Title
The Clinical Significance of Plasma Pentraxin 3 levels for Patients with Diastolic Heart Failure
Scientific Title:Acronym
Pentaraxin 3 in Left Ventricular Diastolic Dysfunction
Region
| Japan |
Condition
Condition
Patients with heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inflammatory markers are closely associated with role of pathogenesis and adverse prognoses in patients with heart failure. C-reactive protein and PTX3, a novel inflammatory marker, predict adverse clinical outcomes in patient with heart failure. However, patients of those study were almost systolic heart failure. The relationship between inflammtory marker and left ventricular diastolic dysfunction are not clearly.
In the present study, we investigated the clinical significance of plasma PTX3 levels in patients with diastolic heart failure. Furthermore, because PTX3 reflects inflammatory status of local tissues, we investigated whether cardiac tissues produce PTX3.
Furthermore, we investigate whether plasma levels of PTX3 could predict occurrence of future cardiovascular events in patients with eart failure with normal ejection fraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The clinical significance of plasma PTX3 levels for patients with left ventricular diastolic dysfunction
Key secondary outcomes
cardiovascular events, which were a composite of CV death, non-fatal myocardial infarction or ischemic stroke, unstable angina, hospitalization for HF, or coronary revascularization.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with heart failure who are admitted to our hospital are enrolled. The diagnosis of heart failure is based on guidelines.
This study also enrolles control subjects in our hospital during the same enrollment period.
Key exclusion criteria
Exclusion criteria include active systemic inflammatory diseases, chronic renal failure requiring hemodialysis, active hepatic diseases, collagen diseases, presence of malignant tumor or acute coronary syndrome within 3 months preceding admission.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto, Japan
TEL
096-373-5175
ogawah@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Matsubara |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto, Japan
TEL
096-373-5175
Homepage URL
j-matsu@kumamoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 07 | Month | 08 | 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
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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Venous blood samples were obtained at the stable condition to measure levels of serum hs-CRP, plasma PTX3, BNP and other biochemical markers.
We also meseured levels of PTX3 at the aortic root and the coronary sinus within 2 minutes in patients who received coronary angiography.
Management information
Registered date
| 2009 | Year | 07 | Month | 08 | Day |
Last modified on
| 2013 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002665
