J-PATCH

JRCT ID: jRCTs031180312

Registered date:15/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pregnant women with previous child with cardiac neonatal lupus
• Date of first enrollment: 03/10/2017
• Target sample size: 26
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: congenital heart block (type II or III) during fetal period or at birth

Secondary Outcome

1) congenital heart block I, II, or III, respectively,
2) cNL (See inclusion criteria)
3) Any sign of myocardial injury, without change in cardiac rate or rhythm, 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.
4) Echocardiographic densities consistent with EFE (excluding mild EFE without cardiac injury)
5) Fetal death not related to cardiac dysfunction
6) Prematurity (gestational age <37 weeks at birth)
7) Birth weight <10% in the context of gestational age
8) Abnormal fluid collection
9) Safety (until delivery except eye examination)
10) Neonatal lupus rash

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Mothers must have anti-SSA/Ro Ab documented.
2. Mothers must have a previous child with cardiac neonatal lupus (cNL) , defined herein as: during the fetal period or at delivery, the presence of heart block (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
3. Mothers with normal Intrauterine pregancy of <=10 weeks (10 weeks and 6 days).
4. Mothers with age>=18
5. Mothers must provide an informed consent (assent if age <18) based on the free will to the explanation using documents

Exclude criteria

1. 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)
2. Mother is taking fluorinated steroids (dexamethasone, betamethasone, intravenously or orally)
3. Mother is taking more than 20mg/d of prednisolone
4. Contraindication of HCQ: history of hypersensitivity to HCQ, retinopathy (except SLE retinopathy)or maculopathy
5. Mothers with a serious condition of either cardiovascular disease, pulmonary disease, liver disease, renal disease, gastrointestinal disease, hematologic disease, or thyroid disease
in reference to Grade 3 adverse events of Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
6. Mothers diagnosed with bipolar disorder, depression with psychotic features, schizophrenia, obsessive-compulsive disorder
7. Mothers known to have difficulty in seeing physicians during the clinical trial
8. Mothers who refuse to observe her child after birth
9. Mothers who physicians in charge judge inappropriate as a subject for this clinical trial

Related Information

• Primary Sponsor: Yokogawa Naoto
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research (KAKENHI), The Ministry of Education,Culture,Sports,Science and Technology