Evidence map›Paper›PMID 34535165›Full record

ArticleTrials2021

Effects of Hydroxychloroquine on endOthelial function in eLDerly with sleep apnea (HOLD): study protocol for a randomized clinical trial.

Leticia Maria Tedesco Silva, Antonio Cortes, Beatriz Rossi, Liliana Boll, Gustavo Waclawovsky, Bruna Eibel, Sandro Cadaval Gonçalves, Maria Claudia Irigoyen, Denis Martinez

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04161339 (Effect of Hydroxychloroquine on Endothelial Function), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 56% 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.

NCT04161339 phase4unknown statusnot on this map

Effect of Hydroxychloroquine on Endothelial Function: a Clinical Trial

TypeinterventionalSponsorInstituto de Cardiologia do Rio Grande do SulRan2019 to 2020Enrolled50ConditionsCardiovascular Diseases, Endothelial Dysfunction, Sleep Apnea, AtherosclerosisArmsHydroxychloroquine, Placebo oral tablet
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Leticia Maria Tedesco SilvaUniversidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. tedescosilva.leticia@gmail.com.
Antonio CortesUniversidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Beatriz RossiInstituto de Cardiologia - Fundação Universitária de Cardiologia (IC-FUC), Porto Alegre, Brazil.
Liliana BollInstituto de Cardiologia - Fundação Universitária de Cardiologia (IC-FUC), Porto Alegre, Brazil.
Gustavo WaclawovskyInstituto de Cardiologia - Fundação Universitária de Cardiologia (IC-FUC), Porto Alegre, Brazil.
Bruna EibelInstituto de Cardiologia - Fundação Universitária de Cardiologia (IC-FUC), Porto Alegre, Brazil.
Sandro Cadaval GonçalvesUniversidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Maria Claudia IrigoyenInstituto de Cardiologia - Fundação Universitária de Cardiologia (IC-FUC), Porto Alegre, Brazil.
Denis MartinezUniversidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Fundação Universitária de Cardiologia · BRUniversidade Federal do Rio Grande do Sul · BRUniversidade de São Paulo · BR

Funding

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul EFP_00014131
6 · The paper itself

Abstract

backgroundSleep apnea and coronary artery disease are prevalent and relevant diseases. The mechanism by which sleep apnea leads to coronary artery disease remains unclear. Intermittent hypoxia, caused by sleep apnea, leads to inflammation and consequent endothelial dysfunction. Endothelial dysfunction precedes the development of atherosclerotic disease and the occurrence of cardiovascular events. Agents that potentially act to improve endothelial function can help prevent cardiovascular events. Patients using immunomodulators due to rheumatic diseases have a lower prevalence of cardiovascular diseases. However, the potential cardioprotective effect of these drugs in patients without autoimmune diseases is not clear. Hydroxychloroquine (HCQ) is an immunomodulator used to treat rheumatoid arthritis and systemic lupus erythematosus. In addition to its anti-inflammatory properties, HCQ reduces cholesterol and blood glucose levels and has antithrombotic effects. The drug is inexpensive and widely available. Adverse effects of HCQ are rare and occur more frequently with high doses.

objectiveIn this randomized clinical trial, the effect of HCQ treatment on endothelial function will be tested in seniors with sleep apnea.

methodsWe will recruit participants over the age of 65 and with moderate-severe sleep apnea from an ongoing cohort. We chose to use this sample already evaluated for sleep apnea for reasons of convenience, but also because the elderly with sleep apnea are vulnerable to heart disease. Endothelial function will be assessed by examining flow-mediated dilation of the brachial artery, the gold standard method, considered an independent predictor of cardiovascular events in the general population and by peripheral arterial tonometry, the most recent and most easily obtained method. Hydroxychloroquine will be used at a dose of 400 mg/daily for 8 weeks. DISCUSSION: Our study aims to obtain evidence, albeit preliminary, of the efficacy of hydroxychloroquine in improving endothelial function and reducing cardiovascular risk markers. If the improvement occurs, we plan to design a randomized multicenter clinical trial to confirm the findings.

trial registrationClinicalTrials.gov NCT04161339 . Registered on November 2019.

Indexed as

Arthritis, RheumatoidCardiovascular DiseasesLupus Erythematosus, SystemicSleep Apnea SyndromesAgedHumansHydroxychloroquineMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeHydroxychloroquineEndothelial functionHydroxychloroquineSleep apnea

Identifiers

PMID34535165
PMCPMC8447592
OpenAlexW3152561565

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.