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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038856
Receipt No. R000044311
Scientific Title A prospective observational cohort study fo deferential ejection and reverse remodeling effect after SAVR and TAVI
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/11

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Basic information
Public title A prospective observational cohort study fo deferential ejection and reverse remodeling effect after SAVR and TAVI
Acronym DEAREST2
Scientific Title A prospective observational cohort study fo deferential ejection and reverse remodeling effect after SAVR and TAVI
Scientific Title:Acronym DEAREST2
Region
Japan

Condition
Condition Severe Aortic valve stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate how valve replacement for severe aortic stenosis affects contraction of both ventricles and to elucidate how they affect heart failure and cardiovascular-related death.
Basic objectives2 Others
Basic objectives -Others It is also aimed at clarifying how reverse remodeling induced by valve replacement and systemic vascular compliance affect cardiac function and the aforementioned changes in time phase.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Maximum displacement distance and time of tricuspid and mitral annulus in speckle tracking method
Key secondary outcomes 1) Cardiac ultrasonography findings
LAD, LVDd, LVDs, IVSth, EF, FS, LVmass, LVMI, RWT, PW: E, PW: A, E / A, DT, e ', s' E / e'
LV tei index, RWMA, valvular disease, aortic valve pressure difference, SV, CO, Zva, GLS, TAPSE, MAPSE, TASV, MASV
2) cardiac output
Echocardiographic findings and cardiac output measurement data by Flo-trac and PAC
3) Patient outcome, preoperative examination data
28-day outcome (mortality, occurrence of heart failure symptoms, occurrence of heart-related events) 1-year outcome (mortality, occurrence of heart failure symptoms, occurrence of heart-related events) Preoperative examination data (Hb, Plt, Alb, Cre, (GFR, BNP)

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 Patients with severe aortic stenosis with pressure range over 40mmHg
Key exclusion criteria 1) Patients with contraindications for transesophageal echocardiography (TEE) insertion
2) Other patients who are deemed inappropriate by the principal investigator
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Ota
Organization Shonan Kamakura General Hospital
Division name Anesthesiology
Zip code 2470083
Address 1370-1, Okamoto, Kamakura city, Kanagawa pref. Japan
TEL 0467461717
Email otacchi@gmail.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Ota
Organization Shonan Kamakura General Hospital
Division name Anesthesiology
Zip code 2470083
Address 1370-1, Okamoto, Kamakura city, Kanagawa pref. Japan
TEL 0467461717
Homepage URL
Email otacchi@gmail.com

Sponsor
Institute Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization None
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 Tokushukai Group Institutional Review Board
Address 1-8-7 Koujimachi, Chiyoda-ku, Tokyo
Tel 0467461717
Email otacchi@gmail.com

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
2020 Year 01 Month 01 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
2018 Year 08 Month 29 Day
Date of IRB
2018 Year 08 Month 29 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study for patients undergoing follow-up at our hospital

Management information
Registered date
2019 Year 12 Month 11 Day
Last modified on
2019 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044311

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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