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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028979
Receipt No. R000033124
Scientific Title Preventive Approach to Congenital Heart Block with Hydroxychloroquine: an investigator-initiated clinical trial using telemedicine in Japan
Date of disclosure of the study information 2017/09/18
Last modified on 2019/03/10

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Basic information
Public title Preventive Approach to Congenital Heart Block with Hydroxychloroquine: an investigator-initiated clinical trial using telemedicine in Japan
Acronym J-PATCH
Scientific Title Preventive Approach to Congenital Heart Block with Hydroxychloroquine: an investigator-initiated clinical trial using telemedicine in Japan
Scientific Title:Acronym J-PATCH
Region
Japan

Condition
Condition Pregnant women with previous child with cardiac neonatal lupus
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether hydroxychloroquine use during pregnancy prevents congenital heart block in pregnant women with previous child with cardiac neonatal lupus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Advanced heart block (type II or III)
[screening fetal echocardiography: biweekly from 18 weeks to 26 weeks]
Key secondary outcomes 1)Prolonged PR interval (>150msec) [screening fetal echocardiography: biweekly from 18 weeks to 26 weeks, EKG at birth, and at 6 months and one year follow up]
2) Any sign of myocardial injury, without change in cardiac rate or rhythm [fetal echocardiography: biweekly from 18 weeks to 26 weeks]
a) shortening fraction <28% = 2 SD below normal mean or qualitatively reduced systolic function; b) cardio-thoracic ratio >0.33; c) hydropic changes; d) moderate/severe tricuspid regurgitation.
3) Echocardiographic densities consistent with EFE confirmed postnatally [screening fetal echocardiography: biweekly from 18 weeks to 26 weeks]
4) Fetal death not related to cardiac dysfunction
An autopsy with full evaluation of the heart will be encouraged but cannot be mandated. If AV block or evidence of a cardiomyopathy can be "proven," then these will provide the basis for final categorization. If not possible, the death will not be considered a recurrence rate but will be reported.
5) NL rash [at birth, at 6 months and 1 year follow up]
6) Prematurity [At birth]
(gestational age <37 weeks at birth)
7) Birth weight <10% in the context of gestational age [At birth]
8) Abnormal fluid collection [At birth]

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Drug: Hydroxychloroquine
Those who meet eligibility criteria will receive 400mg/d of HCQ (two 200mg pills) Mothers already on HCQ will remain on 400mg/d, or escalate to 400mg/d if taking less
than 400mg/d.
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
45 years-old >=
Gender Female
Key inclusion criteria 1. Mothers must have anti-SSA/Ro and/or anti-SSB/La Ab documented.
2. Mothers must have a previous child with cardiac NL, defined herein as: the presence of heart block (1st, 2nd, or 3rd degree) documented by electrocardiogram (EKG), echocardiogram, pacemaker, or statement in the medical record, and/or; presence of cardiac injury, which specifically includes autopsy evidence of a mononuclear infiltrate in the endocardium, myocardium, and pericardium and/or endocardial fibroelastosis (EFE) on echocardiogram always associated with cardiac dysfunction.
3. Pregnancy <=10 weeks.
4. Mother may be taking <=20 mg prednisone
5. Mother may be asymptomatic, or have a rheumatic disease such as SLE or SS.
6. Mother may or may not already be taking HCQ.
Key exclusion criteria 1. Mother does not have Ab to SSA/Ro or SSB/La.
2. Identification of any of the following structural lesions considered causal for CHB, i.e., L-transposition of the great arteries, polysplenia, atrioventricular septal defects, etc)
3. Mother is taking fluorinated steroids (dexamethasone, betamethasone)
4. Contraindication of HCQ: history of hypersensitivity to HCQ, retinopathy (except SLE retinopathy)or maculopathy
5. lack of cooperation of local rheumatologists, obstetricians, and pediatric cardiologists
6. difficulty in visiting hospital or home-visit
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Yokogawa, MD
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Rheumatic Diseases
Zip code
Address 2-8-29, Musashidai, Fuchu-shi, Tokyo, JAPAN 183-8524
TEL 042-323-5111
Email yokogawan@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Yokogawa, MD
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Rheumatic Diseases
Zip code
Address 2-8-29, Musashidai, Fuchu-shi, Tokyo, JAPAN 183-8524
TEL 042-323-5111
Homepage URL
Email yokogawan@aol.com

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization The Ministry of Education,Culture,Sports,Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
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 東京都立多摩総合医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 18 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 09 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 03 Day
Last modified on
2019 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033124

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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