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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021574
Receipt No. 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

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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
Email 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
Email yoshihitp.saijo@tokushima-u.ac.jp

Sponsor
Institute Tokushima university hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024874

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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