Evidence map›Paper›PMID 32907357›Full record

Trial reportCirculation. Arrhythmia and electrophysiology2020

Electrocardiographic QT Intervals in Infants Exposed to Hydroxychloroquine Throughout Gestation.

Deborah M Friedman, Mimi Kim, Nathalie Costedoat-Chalumeau, Robert Clancy, Joshua Copel, Colin K Phoon, Bettina F Cuneo, Rebecca Cohen, Mala Masson, Benjamin J Wainwright and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation. Arrhythmia and electrophysiology, 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 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Hydroxychloroquine and the associated risk of arrhythmias.Global cardiology science & practice · 2024
    Review
  6. Review
  7. Pregnancy and Autoimmune Disease.Deutsches Arzteblatt international · 2022
    Review
  8. Systemic Lupus Erythematosus Management in Pregnancy.International journal of women's health · 2022
    Review
  9. Review
  10. Review
  11. Review
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 2 countries.

Deborah M FriedmanNew York Medical College, Valhalla (D.M.F.).
Mimi KimAlbert Einstein College of Medicine, Bronx, NY (M.K.).
Nathalie Costedoat-ChalumeauCochin Hospital, Paris, France (N.C.-C.).
Robert ClancyNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Joshua CopelYale School of Medicine, New Haven, CT (J.C.).
Colin K PhoonNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Bettina F CuneoUniversity of Colorado School of Medicine, Aurora, CO (B.F.C.).
Rebecca CohenNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Mala MassonNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Benjamin J WainwrightNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Noel ZahrPitié-Salpêtrière University Hospital, Paris, France (N.Z.).
Amit SaxenaNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Peter M IzmirlyNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Jill P BuyonNew York University School of Medicine, New York, NY (R. Clancy, C.K.P., R. Cohen, M.M., B.J.W., A.S., P.M.I., J.P.B.).
Manhattan Theatre Club (United States) · USAlbert Einstein College of Medicine · USHôpital Cochin · FRNew York Medical College · USSorbonne Université · FRUniversity 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

backgroundBased on inhibition of viral replication and limited reports on clinical efficacy, hydroxychloroquine is being considered as prophylaxis and treatment of coronavirus disease-19 (COVID-19). Although hydroxychloroquine is generally considered safe during pregnancy based on studies in patients with systemic lupus erythematosus and other rheumatic conditions, there may still be reluctance to institute this antimalarial during pregnancy for the sole purpose of antiviral therapy.

methodsTo provide data regarding any potential fetal/neonatal cardiotoxicity, we leveraged a unique opportunity in which neonatal ECGs and hydroxychloroquine blood levels were available in a recently completed study evaluating the efficacy of hydroxychloroquine 400 mg daily to prevent the recurrence of congenital heart block associated with anti-SSA/Ro (anti-Sjögren's Syndrome A/Ro) antibodies.

resultsForty-five ECGs were available for corrected QT interval (QTc) measurement, and levels of hydroxychloroquine were assessed during each trimester of pregnancy and in the cord blood, providing unambiguous assurance of drug exposure. Overall, there was no correlation between cord blood levels of hydroxychloroquine and the neonatal QTc (

conclusionsIn aggregate, these data provide reassurances that the maternal use of hydroxychloroquine is associated with a low incidence of infant QTc prolongation. However, if included in clinical COVID-19 studies, early postnatal ECGs should be considered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01379573.

Indexed as

ElectrocardiographyAntiviral AgentsCardiotoxicityDrug Administration ScheduleDrug MonitoringFemaleFetal BloodFetal HeartGestational AgeHeart BlockHeart RateHumansHydroxychloroquineInfantInfant, NewbornMaleAntiviral AgentsHydroxychloroquineCOVID-19heart blockhydroxychloroquineincidencepregnancy

Identifiers

PMID32907357
PMCPMC7668319
OpenAlexW3085114528

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.