UMIN-CTR Clinical Trial

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
Email	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
Email	stakenaka1102@gmail.com

Sponsor
Institute	Hokkaido University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053637