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

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 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


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

Value
https://center6.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