UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029815 |
|---|---|
| Receipt number | R000031726 |
| Scientific Title | The stiffness of liver and spleen, velocity of inferior vena cava, and skip perfusion pressure in patients with heart failure. |
| Date of disclosure of the study information | 2017/11/03 |
| Last modified on | 2018/02/28 21:13:21 |
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Basic information
Public title
The stiffness of liver and spleen, velocity of inferior vena cava, and skip perfusion pressure in patients with heart failure.
Acronym
Echo elastography, velocity of inferior vena cava, and skip perfusion pressure in patients with heart failure.
Scientific Title
The stiffness of liver and spleen, velocity of inferior vena cava, and skip perfusion pressure in patients with heart failure.
Scientific Title:Acronym
Echo elastography, velocity of inferior vena cava, and skip perfusion pressure in patients with heart failure.
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association between echo elastography, velocity of IVC, skin perfusion pressure and prognosis in patients with heart failure
Basic objectives2
Others
Basic objectives -Others
Observational
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular death
Key secondary outcomes
Composite endpoint included all-cause death, cardiovascular death, and heart failure readmission and rates of each event. Serum BNP level.
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 who were admitted our hospital
Age greater than or equal to 20 years old
Obtained written informed consent
Key exclusion criteria
(1) patients with liver cirrhosis
(2) patients with dialysis
(3) patients with acute coronary syndrome
(4) patients with hematopoietic disorders
(5) patients with portal hypertension
(6) patients with acute viral infection (i.e. EB virus)
(7) patients with splenomegaly due to infection (i.e. tuberculosis, malaria, and brucellosis)
(8) patients with splenomegaly due to accumulation diseases
(9) patients with splenomegaly due to autoimmune disorders
(10) patients who can not be performed MRI
(11) patients with arteriosclerosis obliterans in lower limb
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshitaka Okabe |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Cardiology and Cardiac Catheterization Laboratories
Zip code
Address
35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL
045-949-7000
sunyh-hf@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshitaka Okabe |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Cardiology and Cardiac Catheterization Laboratories
Zip code
Address
35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
sunyh-hf@hotmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2017 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow up patients to evaluate mortality, cardiovascular event and laboratory data.
By hospital visit or telephone contact.
Management information
Registered date
| 2017 | Year | 11 | Month | 03 | Day |
Last modified on
| 2018 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031726
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
