UMIN-CTR Clinical Trial

Basic information
Public title	Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis
Acronym	ILLUMINATE-CS
Scientific Title	Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis
Scientific Title:Acronym	ILLUMINATE-CS
Region	Japan

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

Objectives
Narrative objectives1	To evaluate clinical course, effect of conventional therapy, and prognosis in patients with cardiac sarcoidosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Composite cardiac events after diagnosed cardiac sarcoidosis. Cardiac events include HF admission, documented VT/VF, and death.
Key secondary outcomes	1. Change in cardiac function after steroid therapy 2. Resolution of atrioventricular block after steroid therapy 3. Change in inflammatory activity by imaging modality after steroid therapy 4. Efficacy of catheter ablation to ventricular tachycardia

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 with cardiac sarcoidosis from January 1st, 2001 to December 31st, 2017. Diagnosis of CS is according to either Japanese Circulation Society (JCS) criteria proposed in 2016 or the Heart Rhythm Society (HRS) 2014 consensus statement
Key exclusion criteria	The exclusion criterion was the refusal of a patient to be enrolled after notification that he/she is registered to this registry
Target sample size	515

Research contact person
Name of lead principal investigator	1st name Takeru Middle name Last name Nabeta
Organization	Kitasato University School of Medicine
Division name	Cardiovascular Medicine
Zip code	2520373
Address	1-15-1, Kitasato, Minami-ku, Sagamihara
TEL	0427788111
Email	nabetake@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Takeru Middle name Last name Nabeta
Organization	Kitasato University School of Medicine
Division name	Cardiovascular Medicine
Zip code	2520373
Address	1-15-1, Kitasato, Minami-ku, Sagamihara
TEL	0427788111
Homepage URL
Email	nabetake@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato 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	Kitasato University Medical Ethics Organization
Address	1-15-1, Kitasato, Minami-ku, Sagamihara
Tel	0427788111
Email	rinrib@med.kitasato-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	2018 Year 11 Month 25 Day

Related information
URL releasing protocol	None
Publication of results	Published

Result
URL related to results and publications	https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehac323/6619356?searchresul
Number of participants that the trial has enrolled	512
Results	Among 512 registered patients, 148 combined events were observed during a median follow-up of 1042 days. The 10-year estimated event rates for the primary endpoint were 48.1. On multivariable Cox regression, a history of ventricular tachycardia or fibrillation, log-transformed brain natriuretic peptide levels, left ventricular ejection fraction, and post-diagnosis radiofrequency ablation for VT independently predicted the primary endpoint.
Results date posted	2022 Year 07 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 07 Month 04 Day
Baseline Characteristics	Cardiac sarcoidosis were diagnosed according to the recent guidelines. mean age is 62 years. 35.7% is male.
Participant flow	Participants were included retrospectively on each institution.
Adverse events	None
Outcome measures	Referred to the above results
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 11 Month 19 Day
Date of IRB	2018 Year 09 Month 19 Day
Anticipated trial start date	2018 Year 11 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 07 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2022 Year 01 Month 31 Day

Other
Other related information	None

Management information
Registered date	2018 Year 11 Month 22 Day
Last modified on	2022 Year 07 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039878