Evidence map›Paper›PMID 32674792›Full record

Trial reportJournal of the American College of Cardiology2020

Hydroxychloroquine to Prevent Recurrent Congenital Heart Block in Fetuses of Anti-SSA/Ro-Positive Mothers.

Peter Izmirly, Mimi Kim, Deborah M Friedman, Nathalie Costedoat-Chalumeau, Robert Clancy, Joshua A Copel, Colin K L Phoon, Bettina F Cuneo, Rebecca E Cohen, Kimberly Robins and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01379573 (Preventive Approach to Congenital Heart Block With Hydroxychloroquine), which is not on this map. Cited by 90 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 7 pooled it
17.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01379573 phase2completednot on this map

Preventive Approach to Congenital Heart Block With Hydroxychloroquine

TypeinterventionalSponsorNYU Langone HealthRan2011 to 2020Enrolled74ConditionsCongenital Heart Block, Neonatal Lupus, Autoantibody-Associated Heart BlockArmsHydroxychloroquine
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 7 syntheses or guidelines pooled it, 203 citations in OpenAlex.

  1. Pooled it
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  7. Pooled it
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  14. [Sjögren's disease and pregnancy].Zeitschrift fur Rheumatologie · 2026
    Review
  15. Arrhythmias in Autoimmune Diseases: Immune-Mediated Mechanisms and Management.Journal of cardiovascular development and disease · 2026
    Review
  16. Article
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  19. Review
  20. Article

30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 2 countries.

Peter IzmirlyNew York University School of Medicine, New York, New York. Electronic address: Peter.Izmirly@nyulangone.org.
Mimi KimAlbert Einstein College of Medicine, Bronx, New York.
Deborah M FriedmanNew York Medical College, Valhalla, New York.
Nathalie Costedoat-ChalumeauAPHP, Hospital Cochin, Paris, France.
Robert ClancyNew York University School of Medicine, New York, New York.
Joshua A CopelYale School of Medicine, New Haven, Connecticut.
Colin K L PhoonNew York University School of Medicine, New York, New York.
Bettina F CuneoUniversity of Colorado School of Medicine, Aurora, Colorado.
Rebecca E CohenNew York University School of Medicine, New York, New York.
Kimberly RobinsNew York University School of Medicine, New York, New York.
Mala MassonNew York University School of Medicine, New York, New York.
Benjamin J WainwrightNew York University School of Medicine, New York, New York.
Noel ZahrPitié-Salpêtrière University Hospital, Paris, France.
Amit SaxenaNew York University School of Medicine, New York, New York.
Jill P BuyonNew York University School of Medicine, New York, New York. Electronic address: https://twitter.com/JillBuyonMD.
New York University · USAlbert Einstein College of Medicine · USHôpital Cochin · FRNew York Medical College · USSorbonne Université · FRTwitter (United States) · USUniversity of Colorado Denver · USYale University · US

Funding

Preventive Approach to Congenital Heart Block with Hydroxychloroquine (PATCH)R01HD079951 · NICHD · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BUYON, JILL P · 2015 to 2019
$1.4M
Preventive Approach to Congenital Heart Block with Hydroxychloroquine (PATCH)R03HD069986 · NICHD · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BUYON, JILL P · 2012 to 2014
$249k
NICHD NIH HHS R01 HD079951NICHD NIH HHS R03 HD069986
6 · The paper itself

Abstract

backgroundExperimental and clinical evidence support the role of macrophage Toll-like receptor signaling in maternal anti-SSA/Ro-mediated congenital heart block (CHB).

objectivesHydroxychloroquine (HCQ), an orally administered Toll-like receptor antagonist widely used in lupus including during pregnancy, was evaluated for efficacy in reducing the historical 18% recurrence rate of CHB.

methodsThis multicenter, open-label, single-arm, 2-stage clinical trial was designed using Simon's optimal approach. Anti-SSA/Ro-positive mothers with a previous pregnancy complicated by CHB were recruited (n = 19 Stage 1; n = 35 Stage 2). Patients received 400 mg daily of HCQ prior to completion of gestational week 10, which was maintained through pregnancy. The primary outcome was 2° or 3° CHB any time during pregnancy, and secondary outcomes included isolated endocardial fibroelastosis, 1° CHB at birth and skin rash.

resultsBy intention-to-treat (ITT) analysis, 4 of 54 evaluable pregnancies resulted in a primary outcome (7.4%; 90% confidence interval: 3.4% to 15.9%). Because 9 mothers took potentially confounding medications (fluorinated glucocorticoids and/or intravenous immunoglobulin) after enrollment but prior to a primary outcome, to evaluate HCQ alone, 9 additional mothers were recruited and followed the identical protocol. In the per-protocol analysis restricted to pregnancies exposed to HCQ alone, 4 of 54 (7.4%) fetuses developed a primary outcome as in the ITT. Secondary outcomes included mild endocardial fibroelastosis (n = 1) and cutaneous neonatal lupus (n = 4).

conclusionsThese prospective data support that HCQ significantly reduces the recurrence of CHB below the historical rate by >50%, suggesting that this drug should be prescribed for secondary prevention of fetal cardiac disease in anti-SSA/Ro-exposed pregnancies. (Preventive Approach to Congenital Heart Block With Hydroxychloroquine [PATCH]; NCT01379573).

Indexed as

Administration, OralAdultAutoantibodiesDose-Response Relationship, DrugEnzyme InhibitorsFemaleFetal DiseasesFollow-Up StudiesHeart BlockHumansHydroxychloroquineInfant, NewbornMalePregnancyProspective StudiesSecondary PreventionAutoantibodiesEnzyme InhibitorsHydroxychloroquineanti-SSA/Ro antibodiescongenital heart blockhydroxychloroquineneonatal lupusprevention

Identifiers

PMID32674792
PMCPMC7394202
OpenAlexW3041744260

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.