UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059912 |
|---|---|
| Receipt number | R000067761 |
| Scientific Title | Association between preoperative phase angle and 1-year mortality in patients undergoing transcatheter aortic valve implantation: a prospective observational study |
| Date of disclosure of the study information | 2025/11/28 |
| Last modified on | 2025/11/28 08:01:39 |
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Basic information
Public title
A study on body composition and prognosis in patients undergoing catheter treatment for aortic valve stenosis
Acronym
A study on cardiac treatment and body composition
Scientific Title
Association between preoperative phase angle and 1-year mortality in patients undergoing transcatheter aortic valve implantation: a prospective observational study
Scientific Title:Acronym
Phase angle and prognosis in TAVI patients
Region
| Japan |
Condition
Condition
aortic valve stenosis
Classification by specialty
| Cardiology | Anesthesiology | Cardiovascular surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the association between preoperative phase angle (PhA) and 1-year all-cause mortality in patients undergoing TAVI, and to evaluate whether PhA remains an independent prognostic factor after adjustment for established risk factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is all-cause mortality within 1 year after TAVI. Mortality will be ascertained from hospital electronic medical records, outpatient clinic records, and, if necessary, telephone follow-up. The time point of evaluation is defined as one year after the date of the TAVI procedure.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo transcatheter aortic valve implantation (TAVI) at our institution
Patients capable of providing written informed consent
Key exclusion criteria
Patients with pacemaker or implantable cardioverter-defibrillator (ICD), in whom bioelectrical impedance analysis (BIA) is contraindicated
Emergency cases
Patients on chronic dialysis
Valve-in-valve cases (redo transcatheter valve implantation within a previously implanted bioprosthetic valve)
Patients undergoing TAVI via non-transfemoral approaches
Patients converted to open surgical aortic valve replacement
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Fujiwara |
| Middle name | |
| Last name | Atsushi |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
atsushi.fujiwara@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsui |
| Middle name | |
| Last name | Hiroaki |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
hiroaki.mitsui@ompu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka Medical and Pharmaceutical University
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
Department of Anesthesiology, Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
Tel
072-683-1221
hiroaki.mitsui@ompu.ac.jp
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
| 2025 | Year | 11 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative phase angle (PhA) will be measured using bioelectrical impedance analysis (BIA). Clinical data including laboratory findings (albumin, hemoglobin, creatinine, BNP, LVEF, etc.) and comorbidities will be collected from electronic medical records. Patients will be followed for 1 year after TAVI by reviewing hospital records, outpatient records, or telephone contact to ascertain all-cause mortality (primary outcome).
Management information
Registered date
| 2025 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067761
