UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047012 |
|---|---|
| Receipt number | R000053637 |
| Scientific Title | Analysis and prognostic significance of biological samples from patients with severe heart failure requiring ventricular assist device (VAD) and heart transplantation |
| Date of disclosure of the study information | 2022/02/26 |
| Last modified on | 2022/08/28 13:55:15 |
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Basic information
Public title
Analysis and prognostic significance of biological samples from patients with severe heart failure requiring ventricular assist device (VAD) and heart transplantation
Acronym
Research on biological samples from patients with severe heart failure requiring VAD and heart transplantation
Scientific Title
Analysis and prognostic significance of biological samples from patients with severe heart failure requiring ventricular assist device (VAD) and heart transplantation
Scientific Title:Acronym
Research on biological samples from patients with severe heart failure requiring VAD and heart transplantation
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will accumulate clinical information and biological samples from patients with VAD and severe heart failure requiring heart transplantation, and conduct pathological analysis as well as comprehensive analysis at each level of genome, RNA, protein, epigenome, and mitochondria (multi-layered omics analysis) to identify key factors in the pathogenesis and pathogenesis of myocardial damage and complications. In addition, we aim to identify key factors in the pathogenesis of myocardial disorders and complications. In addition, we will examine the relationship with prognosis by examining endpoints on a continuous and long-term basis.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between findings from various biological samples and incidence of all-cause mortality, cardiovascular death, and heart failure hospitalization
Key secondary outcomes
Relationship between findings from various biological samples and infections (driveline infection, pocket infection, sepsis, mediastinal sinusitis, etc.), heart failure (pump dysfunction, right heart failure), device failure (pump, controller), device thrombosis, hemolysis, arrhythmia, multiple organ failure (liver, kidney, lung, etc.), cerebral neuropathy (stroke, cerebral hemorrhage), gastrointestinal bleeding, and aortic regurgitation.
The relationship between findings from various biological samples and acute complications (acute rejection, graft failure, infection, multi-organ failure, renal failure) and chronic complications (transplant coronary artery lesions, malignancy, lymphoma) after heart transplantation.
Relationship between findings from various biological samples and patient background, cardiac MRI, cardiac PET, and blood test data.
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
(1) Age 18 years or older at the time of obtaining consent
(2) Those who have freely and voluntarily consented to participate in this research for research subjects using specimens, and those who do not refuse to participate in the research for research subjects using only medical information.
Key exclusion criteria
(1) Persons who are judged by the Principal Investigator to be inappropriate as research subjects.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
tnagai@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Sakae |
| Middle name | |
| Last name | Takenaka |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
0608638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL
0117066973
Homepage URL
stakenaka1102@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 26 | 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
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053637
