UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038856 |
|---|---|
| Receipt number | 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 | 2024/10/08 17:26:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
otacchi@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044311
