UMIN-CTR Clinical Trial

Basic information
Public title	Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Acronym	Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Scientific Title	Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Scientific Title:Acronym	Antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
Region	Japan

Condition
Condition	fetal tachycarrhythmia(supraventricular tachycadia, atrial flutter)
Classification by specialty	Cardiology Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of transplacental anti-arrhythmic treatment for fetal tachycarrhythmias
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	sinus rhythm or fetal heart rate <180bpm (the half of 30 min fetal echocardiogram and/ or 40 min CTG )
Key secondary outcomes	1. IUFD 2. rate of preterm birth 3. rate of cesarean section 4. fetal heart rate, hydrops 5. neonatal arrhythmias 6. CNS findings in neonate 7. survival rate at 1 month 8. tachyarrhythmias at 1 month (9.MRI at 1month(corrected)) (10.development at 1y 6m(corrected)) (11.development at 3y(corrected))

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	These antiarrhythmic agency are administered to pregnant women as treatment for fetal supraventricular tachycardia with short VA interval (start with 2nd for fetal hydrops) 1st. digoxin 2nd. digoxin+sotalol 3rd. digoxin+flecainide These antiarrhythmic agency are administered to pregnant women as treatment for fetal supraventricular tachycardia with long VA interval 1st. sotalol 2nd. flecainide These antiarrhythmic agency are administered to pregnant women as treatment for fetal atrial flutter. (start with 2nd for fetal hydrops) 1st. digoxin 2nd. digoxin+sotalol 3rd. digoxin+flecainide
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	1. sustained fetal tachycaarrhythmias with these diagnoses 1) supraventricular tachycardia with short VA interval 2) supraventricular tachycardia with short VA interval 3) atrial flutter 2.22w0d~36w6d 3.singleton 4.IC
Key exclusion criteria	1. impossible to obtain IC due to the mental problem 2. risk for maternal health (ex; allergic to anti-arrhythmic agency) 3. Dr's judgement
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yasuki Middle name Last name Maeno
Organization	Kurume University School of Medicine
Division name	Department of Pediatrics
Zip code	830-0011
Address	Kurume, Fukuoka
TEL	+81-942-35-3311
Email	yasukim@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Takekazu Middle name Last name Miyoshi
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Perinatology and Gynecology
Zip code	565-8565
Address	5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL	+81-6-6833-5012
Homepage URL	http://en.fetusjapan.jp/
Email	taijihin@ml.ncvc.go.jp

Sponsor
Institute	National cerebral and cardiovascular center of Japan
Institute
Department

Funding Source
Organization	The Ministry of Health, Labor and Welfare of Japan (Health and Labour Science Research Grants for Clinical Research for New Medicine)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National cerebral and cardiovascular center of Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Ethics Committee of National Cerebral and Cardiovascular Center
Address	5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
Tel	+81-6-6833-5012
Email	plandiv@ml.ncvc.go.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	国立循環器病研究センター（大阪府）、久留米大学病院（福岡県）、大阪母子医療センター（大阪府）、国立成育医療研究センター（東京都）、神奈川県立こども医療センター（神奈川県）、筑波大学（茨城県）、東邦大学医療センター大森病院（東京都）、北海道大学病院（北海道）、兵庫県立こども病院（兵庫県）、長野県立こども病院（長野県）、静岡県立こども病院（静岡県）、神戸市立医療センター中央市民病院（兵庫県）、三重大学病院（三重県）、岡山医療センター（岡山県）、大阪大学病院（大阪府）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 01 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629695/
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	2010 Year 09 Month 13 Day
Date of IRB	2010 Year 07 Month 16 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2017 Year 05 Month 09 Day
Date of closure to data entry	2018 Year 05 Month 31 Day
Date trial data considered complete	2018 Year 06 Month 21 Day
Date analysis concluded	2018 Year 07 Month 10 Day

Other
Other related information	Because the accumulation of the cases delayed, we extended a registration period until December, 2017.

Management information
Registered date	2010 Year 09 Month 27 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005120

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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