UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047410 |
|---|---|
| Receipt number | R000054068 |
| Scientific Title | Mid-term results of surgical aortic valve replacement with bioprostheses in hemodialysis patients |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2022/04/06 10:05:36 |
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Basic information
Public title
Mid-term results of surgical aortic valve replacement with bioprostheses in hemodialysis patients
Acronym
Mid-term results of surgical aortic valve replacement with bioprostheses in hemodialysis patients
Scientific Title
Mid-term results of surgical aortic valve replacement with bioprostheses in hemodialysis patients
Scientific Title:Acronym
Mid-term results of surgical aortic valve replacement with bioprostheses in hemodialysis patients
Region
| Japan |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, the number of new patients undergoing hemodialysis (HD) has been increasing, primarily because of the aging population and the evolution of HD techniques. The number of annual deaths has also been increasing. According to a report by the Japanese Society for HD therapy, heart failure (HF) was the most common cause of death in 2019 (22.7%), followed by infections (21.5%), malignancies (8.7%), cerebrovascular disease (5.7%), and myocardial infarction (MI) (3.9%). The frequencies of calcification associated with intimal atherosclerosis and tunica media are high in HD patients, and atherosclerosis and calcification are risk factors for cardiovascular disease. Moreover, ectopic calcification reportedly progresses more rapidly in HD patients than it does in non-HD patients. The incidence of aortic stenosis (AS) in HD patients has been increasing annually and is a leading cause of death. In surgical aortic valve replacement (SAVR), surgical mortality and morbidity rates are also higher in HD patients than in non-HD patients. Elucidating the prognostic factors is important to improve the prognosis of SAVR in HD patients. Therefore, in this study, we investigated the preoperative and postoperative risk factors for mid-term mortality following SAVR with bioprostheses (SAVR-BP) in HD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five-year mortality risk factors
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
surgical aortic valve replacement with bioprostheses
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent SAVR-BP for HD patients with aortic stenosis at Dokkyo Medical University Hospital between July 2009 and December 2020 included.
Key exclusion criteria
patients who deemed inappropriate for aortic valve repair.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Shibasaki |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Cardiac and Vascular Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi,Japan
TEL
0282861111
sibasaki@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Shibasaki |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Cardiac and Vascular Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi,Japan
TEL
0282861111
Homepage URL
sibasaki@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University School of Medicine
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
Dokkyo Medical University School of Medicine
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi, Japan
Tel
0282-86-1111
sibasaki@dokkyomed.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
| 2022 | Year | 04 | Month | 06 | 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
57
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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 10 | 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
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054068
