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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019937
Receipt No. R000023011
Scientific Title A multicenter prospective study on prediction of right heart failure and prognosis in patients with severe heart failure after left ventricular assist device implantation
Date of disclosure of the study information 2015/11/26
Last modified on 2018/11/28

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Basic information
Public title A multicenter prospective study on prediction of right heart failure and prognosis in patients with severe heart failure after left ventricular assist device implantation
Acronym A multicenter study on usefulness of right ventricular function indices in LVAD patients
Scientific Title A multicenter prospective study on prediction of right heart failure and prognosis in patients with severe heart failure after left ventricular assist device implantation
Scientific Title:Acronym A multicenter study on usefulness of right ventricular function indices in LVAD patients
Region
Japan

Condition
Condition Patients with severe heart failure before and after left ventricular assist device implantation over 15 years old
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine useful right ventricular function indices for prediction of right heart failure and prognosis.
Basic objectives2 Others
Basic objectives -Others To determine useful right ventricular function indices for prediction of right heart failure and prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) All-cause mortality
(2) Right heart failure
Key secondary outcomes Correlation between RVSWI and right ventricular function indices by echocardiography

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with severe heart failure before and after left ventricular assist device implantation over 15 years old
Key exclusion criteria (1) Informed consent cannot be obtained
(2) Ineligible by other reasons judged by the investigators
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsutsui
Organization Hokkaido University Hospital
Division name Cardiovascular Medicine
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-6973
Email htsutsui@med.hokudai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Daisuke Murai
Organization Hokkaido University Hospital
Division name Cardiovascular Medicine
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-6973
Homepage URL
Email dmurai_h@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University Hospital
Tokyo University Hospital
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
2015 Year 11 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2014 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter prospective observational study

Management information
Registered date
2015 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023011

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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