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.DiscussionOur 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.
Highlights
Background and rationale {6a} Obstructive sleep apnea (OSA) and cardiovascular disease In a meta-analysis, the prevalence of sleep apnea in the general adult population ranges from 6% to 17%, reaching 49% at advanced ages [1]
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 obtained method
Our study aims to obtain evidence, albeit preliminary, of the efficacy of hydroxychloroquine in improving endothelial function and reducing cardiovascular risk markers
Summary
Study setting {9} The study is conducted in the research laboratory of two academic hospitals in Porto Alegre, Brazil: Hospital de Clínicas de Porto Alegre and Instituto de Cardiologia do Rio Grande do Sul. Main outcome Difference between the two groups on endothelial function measured by FMD (change of percentage of dilatation of brachial artery diameter from baseline) and PAT (change of reactive hyperemia index of finger from baseline) after 8 week of intervention. Each participant will match the bottle with the number that the participant will receive in the plan Both patients and researchers involved with either primary or secondary outcome measures will be blinded to the patient’s allocation. All records that contain names or other personal identifiers, such as locator forms and informed consent forms, will be stored separately from study records identified by code number
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