UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Acronym	Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Scientific Title	Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Scientific Title:Acronym	Relationship between corticosteroid therapy for cardiac sarcoidosis and ventricular arrhythmia
Region	Japan

Condition
Condition	Cardiac sarcoidosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of corticosteroid therapy on ventricular arrhythmia.
Basic objectives2	Others
Basic objectives -Others	Also, to clarify the relationship between ventricular arrhythmia and FDG-PET uptake.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ventricular arrhythmia,including ventricular fibrillation/tachycardia and ventricular premature contraction by 24h-Holter ECG at day3,7,21 after initiation of steroid therapy. Cardiac FDG-PET uptake before and after(1-2month) introduction of steroid therapy.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed with cardiac sarcoidosis and scheduled to undergo corticosteroid therapy.
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masayuki Takamura
Organization	Kanazawa University Graduate School of Advanced Preventive Medical Sciences
Division name	Department of System Biology
Zip code
Address	13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL	076-265-2000
Email	mtakamura@m-kanazawa.jp

Public contact
Name of contact person	1st name Middle name Last name Shunichiro Hondo
Organization	Graduate School of Advanced Preventive Medical Sciences
Division name	Department of System Biology
Zip code
Address	13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL	076-265-2000
Homepage URL
Email	shunichiro.h.27@gmail.com

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 03 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	Completed
Date of protocol fixation	2016 Year 12 Month 21 Day
Date of IRB	2016 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 12 Month 21 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other

Other related information

We register patients who are diagnosed with cardiac sarcoidosis and scheduled to undergo corticosteroid therapy. The objective of this study is to clarify the relationship between the severity of cardiac inflammation and ventricular arrhythmia after initiation steroid therapy. We evaluate ventricular arrhythmia,including ventricular fibrillation/tachycardia and ventricular premature contraction by 24h-Holter ECG at day3,7,21 after initiation of steroid therapy. Also, we perform cardiac FDG-PET uptake before and after(1-2month) introduction of steroid therapy.

Management information
Registered date	2017 Year 03 Month 30 Day
Last modified on	2022 Year 04 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030657