UMIN-CTR Clinical Trial

Basic information
Public title	Effect on durability of bovine pericardial valve after replacement of heart valve
Acronym	ENDURANCE
Scientific Title	Effect on durability of bovine pericardial valve after replacement of heart valve
Scientific Title:Acronym	ENDURANCE
Region	Japan

Condition
Condition	Status post aortic valve replacement with bioprosthetic valve
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Statin therapy would halt the progression of calcification of bioprosthetic valve. We evaluate the favorable effect of statins to the calcification of the bioprosthetic valve and its durability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Primary outcomes: Velocity and pressure gradient of bioprosthetic aortic valve (6, 12, 24, 36 months after AVR)
Key secondary outcomes	Secondary outcomes: Calcification score (Agatston score) of bioprosthetic aortic valve (24months after AVR)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Interventions:Livalo(pitavastatin) Period:3-5years medication:livalo 2~4mg/day
Interventions/Control_2	control:no medication Period:3-5years
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 underwent AVR operation using bioprosthetic valve.
Key exclusion criteria	hyperlipidemia coronary artery disease malignancy
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kumagai Kiichiro
Organization	Tohoku University
Division name	Department of Cardiovascular Surgery
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7222
Email

Public contact
Name of contact person	1st name Middle name Last name Kumagai Kiichiro
Organization	Tohoku University
Division name	Research Division of Sciences for Aortic Disease
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7222
Homepage URL
Email	kkumagai@med.tohoku.ac.jp

Sponsor
Institute	Department of Cardiovascular Surgery, Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tohoku Kosei Nenkin hospital Sendai Open hospital Miyagi Cardiovascular and respiratory center
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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 15 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	2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2015 Year 01 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 01 Day
Date analysis concluded	2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2012 Year 06 Month 15 Day
Last modified on	2020 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004435