UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021574 |
|---|---|
| Receipt number | R000024874 |
| Scientific Title | Clinical utility of preload stress echocardiography and the value of the reaction to heart haemodynamics by preload stress |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/23 07:30:25 |
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Basic information
Public title
Clinical utility of preload stress echocardiography and the value of the reaction to heart haemodynamics by preload stress
Acronym
Clinical utility of preload stress echocardiography and the value of the reaction to heart haemodynamics by preload stress
Scientific Title
Clinical utility of preload stress echocardiography and the value of the reaction to heart haemodynamics by preload stress
Scientific Title:Acronym
Clinical utility of preload stress echocardiography and the value of the reaction to heart haemodynamics by preload stress
Region
| Japan |
Condition
Condition
cardiac failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to assese efficacy of LPP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiac event and admisson for heart failure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Dr.MEDOMER
Interventions/Control_2
Cardiac failure medicine(frosemide, aldosterone antagonist, beta blocker, ACE-inhibitor)
follow up:3yars
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cardiac failure
Key exclusion criteria
Moderate and severe valve diseases
Atrial fibrillation
Deep vein thrombus
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Yamada |
Organization
Tokushima university hospital
Division name
Cardiovascular medicine
Zip code
Address
Kuramoto-cho 2-50-1 tokushimashi Tokushima Japan
TEL
09098296040
yoshihitp.saijo@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Saijo |
Organization
Tokushima university hospital
Division name
Cardiovascular medicine
Zip code
Address
Kuramoto-cho 2-50-1 tokushimashi Tokushima Japan
TEL
09098396040
Homepage URL
yoshihitp.saijo@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima university 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
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
| 2016 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2016 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024874
