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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023653
Receipt No. R000027188
Scientific Title Treatment and prognosis of heart valve registry
Date of disclosure of the study information 2016/08/17
Last modified on 2019/02/25

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Basic information
Public title Treatment and prognosis of heart valve registry
Acronym Heart valve registry
Scientific Title Treatment and prognosis of heart valve registry
Scientific Title:Acronym Heart valve registry
Region
Japan

Condition
Condition aortic stenosis/mitral regurgitation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. We reveal the natural history about occurrence of cardiovascular events, the pace of the illness and that factor of the patients of aortic stenosis/mitral regurgitation. And we reveal the proper timing to offer invasive procedure.
2. We record detail of contents of procedure (surgical operation, Transcatheter Aortic Valve Implantation and Mitral Clip) and follow-up, we reveal the incidence of adverse events related to procedure or surgical result. In addition, we reveal factors affecting the incidence of adverse events and the prognosis after procedure.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes During follow the natural history:
1. Mortality (all cause mortality, cardiovascular death, non-cardiovascular death)
2. Invasive procedure (surgical aortic valve replacement, mitral valve replacement, Transcatheter Aortic Valve Implantation, mitral valvuloplasty and Mitral Clip)
3. Admission of heart failure
4. Progression of heart valve by transthoracic echocardiography (increase of max velocity and pressure gradient, decrease of aortic valve area, and exacerbation of mitral regurgitation)

After the invasive procedure:
1. Perioperative period: in-hospital death, complication (myocardial infarction, cardiac tamponade, vascular accident, auriculoventricular block for needing pacemaker, cerebral infarction, bleeding for needing blood transfusion)
2. Follow-up 1year, 2year, 3year, 4year, 5year after procedure: presence or absence of admission of heart failure, presence or absence of the death (cardiovascular death, non-cardiovascular death)
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who undergo transthoracic echocardiography at Keio University hospital and satisfy the following any items.
A. A patient who has more than moderate aortic valvular stenosis
B. A patient who has more than moderate mitral regurgitation
Key exclusion criteria The patients who are under the 20 years old or who are found unfit to be respondent to a survey by physician-in-charge
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Hayashida
Organization Keio University Hospital
Division name cardiovascular department
Zip code
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Email k-hayashida@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromu Hase
Organization Keio University Hospital
Division name cardiovascular department
Zip code
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email hiromuhase0313@keio.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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 08 Month 17 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 22 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
2028 Year 04 Month 30 Day
Date trial data considered complete
2028 Year 04 Month 30 Day
Date analysis concluded

Other
Other related information Study design: An observational study
Way for subscription: Explain the content of this research verbally using an explanatory document and obtain consent to participate in this research. We present a information of study implementation and Opt-out document about this clinical research to Keio University Hospital Website, Clinical Research Promotion Center Website and Cardiovascular Internal Medicine Website, and we release the content of this study implementation. We give an Opt-out document to such patients needs in any way. The cases of the patient who refuse registration, we indicate so on the clinical record and we don't collect information.
Term of registration: 5-years

Management information
Registered date
2016 Year 08 Month 17 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027188

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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