UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028979 |
|---|---|
| Receipt number | 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 10:15:22 |
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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
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
yokogawan@aol.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033124
