UMIN-CTR Clinical Trial

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
Email	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
Email	sibasaki@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054068