UMIN-CTR Clinical Trial

Basic information
Public title	The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Acronym	The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Scientific Title	The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Scientific Title:Acronym	The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of chronic inflammationon atrial remodeling.
Basic objectives2	Others
Basic objectives -Others	To clarify the relationship between inflammationon along with gut dysbiosis and atrial remodeling.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	relation between peripheral blood monocytes/lymphocytes activity along with gut microbiota and atrial remodeling such as low voltage zone.
Key secondary outcomes	relation between metabolites and atrial remodeling.

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	20 years-old <
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The atrial fibrillation patients treat with catheter ablation in Kobe university.
Key exclusion criteria	1. rejection 2. sCr>1.5mg.dl, CRP>0.3mg/dl, chronic inflammatory disease, OMI, pregnant women, NSAIDs and steroid user
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Fukuzawa
Organization	Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	658-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5846
Email	kfuku@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Fukuzawa
Organization	Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	658-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5846
Homepage URL
Email	kfuku@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

Funding Source
Organization	Kobe 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	Kobe University Clinical Research Ethical Committee
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel	078-382-6669
Email	chiken@med.kobe-u.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	2017 Year 07 Month 25 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	2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this study, we investige the gut dysbiosis and its related endotoxemia/inflammation in patients with atrial fibrillation. Furthermore, we identify the metabolites involved in the pathogenesis of atrial fibrillation.

Management information
Registered date	2017 Year 07 Month 25 Day
Last modified on	2019 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032476