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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008178
Receipt No. R000004435
Scientific Title Effect on durability of bovine pericardial valve after replacement of heart valve
Date of disclosure of the study information 2012/06/15
Last modified on 2020/09/08

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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

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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