Evidence map›Paper›PMID 34327732›Full record

Trial reportBritish journal of clinical pharmacology2022

Effect of hydroxychloroquine on the cardiac ventricular repolarization: A randomized clinical trial.

Boukje C Eveleens Maarse, Claus Graff, Jørgen K Kanters, Michiel J van Esdonk, Michiel J B Kemme, Aliede E In 't Veld, Manon A A Jansen, Matthijs Moerland, Pim Gal

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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

9 authors at 5 institutions in 2 countries.

Boukje C Eveleens MaarseCentre for Human Drug Research, Leiden, The Netherlands.ORCID 0000-0003-1763-3122
Claus GraffDepartment of Health Science and Technology, Aalborg University, Aalborg, Denmark.
Jørgen K KantersLaboratory of Experimental Cardiology, University of Copenhagen, Copenhagen, Denmark.
Michiel J van EsdonkCentre for Human Drug Research, Leiden, The Netherlands.ORCID 0000-0001-8159-0273
Michiel J B KemmeDepartment of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.
Aliede E In 't VeldCentre for Human Drug Research, Leiden, The Netherlands.
Manon A A JansenCentre for Human Drug Research, Leiden, The Netherlands.
Matthijs MoerlandCentre for Human Drug Research, Leiden, The Netherlands.
Pim GalCentre for Human Drug Research, Leiden, The Netherlands.
Leiden University Medical Center · NLCentre for Human Drug Research · NLAalborg University · DKAmsterdam Neuroscience · NLUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsHydroxychloroquine has been suggested as possible treatment for severe acute respiratory syndrome-coronavirus-2. Studies reported an increased risk of QTcF-prolongation after treatment with hydroxychloroquine. The aim of this study was to analyse the concentration-dependent effects of hydroxychloroquine on the ventricular repolarization, including QTcF-duration and T-wave morphology.

methodsTwenty young (≤30 y) and 20 elderly (65-75 y) healthy male subjects were included. Subjects were randomized to receive either a total dose of 2400 mg hydroxychloroquine over 5 days, or placebo (ratio 1:1). Follow-up duration was 28 days. Electrocardiograms (ECGs) were recorded as triplicate at baseline and 4 postdose single recordings, followed by hydroxychloroquine concentration measurements. ECG intervals (RR, QRS, PR, QTcF, J-Tpc, Tp-Te) and T-wave morphology, measured with the morphology combination score, were analysed with a prespecified linear mixed effects concentration-effect model.

resultsThere were no significant associations between hydroxychloroquine concentrations and ECG characteristics, including RR-, QRS- and QTcF-interval (P = .09, .34, .25). Mean ΔΔQTcF-interval prolongation did not exceed 5 ms and the upper limit of the 90% confidence interval did not exceed 10 ms at the highest measured concentrations (200 ng/mL). There were no associations between hydroxychloroquine concentration and the T-wave morphology (P = .34 for morphology combination score). There was no significant effect of age group on ECG characteristics.

conclusionIn this study, hydroxychloroquine did not affect ventricular repolarization, including the QTcF-interval and T-wave morphology, at plasma concentrations up to 200 ng/mL. Based on this analysis, hydroxychloroquine does not appear to increase the risk of QTcF-induced arrhythmias.

Indexed as

COVID-19 Drug TreatmentLong QT SyndromeAgedElectrocardiographyHeart RateHumansHydroxychloroquineMaleSARS-CoV-2Hydroxychloroquinecardiac ventricular repolarizationconcentration-effect analysiselectrocardiogramhydroxychloroquineQT-interval

Identifiers

PMID34327732
PMCPMC8444885
OpenAlexW3184152419

What Socratic holds

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Registered trials

None linked

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 Socratic graph.