UMIN-CTR Clinical Trial

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
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
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	Completed
Date of protocol fixation	2014 Year 06 Month 13 Day
Date of IRB	2014 Year 06 Month 13 Day
Anticipated trial start date	2014 Year 06 Month 13 Day
Last follow-up date	2019 Year 03 Month 31 Day
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	2021 Year 06 Month 01 Day

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