UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034358 |
|---|---|
| Receipt number | R000039160 |
| Scientific Title | The clinical significance of pulse wave velocity in patients with heart failure with reduced ejection fraction. |
| Date of disclosure of the study information | 2018/10/03 |
| Last modified on | 2018/10/02 16:34:53 |
* 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 pulse wave velocity in patients with heart failure with reduced ejection fraction.
Acronym
Heart failure with reduced ejection fraction and PWV.
Scientific Title
The clinical significance of pulse wave velocity in patients with heart failure with reduced ejection fraction.
Scientific Title:Acronym
Heart failure with reduced ejection fraction and PWV.
Region
| Japan |
Condition
Condition
heart failure with reduced ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between PWV and other biomaker of heart failure in patients with heart failure with reduced ejection fraction and to investigate the prognostic involvement of PWV in the future cardiovascular events in patients with heart failure with reduced ejection fraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemicstroke, re-hospitalization for heart failure, or coronary revascularization
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with heart failure who were hospitalized in Kumamoto Univercity hospital
Key exclusion criteria
Do not meet diagnostic criteria for heart failure with reduced ejection fraction
End stage of chronic kidney disease
Do not measure ABI
severe valvular disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Tsujita |
Organization
Graduate School of Medical Science,Kumamoto University
Division name
cardiology
Zip code
Address
1-1-1 Honjo Tyuouku Kumamotoshi
TEL
0963735175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Takae |
Organization
Kumamoto univercity hospital
Division name
cardiology
Zip code
Address
1-1-1 Honjo Tyuouku Kumamotoshi
TEL
0963735175
Homepage URL
qqcv2t3d@yahoo.co.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
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
| 2018 | Year | 10 | Month | 03 | 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
| 2007 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients were followed every month at the outpatients clinic until July 2015 or until endopoint occured.
Management information
Registered date
| 2018 | Year | 10 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039160
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
