Clinical trial NCT04161339: Anti-Inflammatory Drug and Endothelial Function
Official title: Effect of Hydroxychloroquine on Endothelial Function: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiovascular Diseases
Endothelial Dysfunction
Sleep Apnea
Atherosclerosis
Coronary Artery Disease
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2019-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized double-blinded clinical trial, 400mg of hydroxychloroquine will be given daily to people over the age of 65 years with moderate-severe obstructive sleep apnea for 8 weeks. The aim of this study is to test whether hydroxychloroquine can improve endothelial function.

Detailed description: Sleep apnea and coronary artery disease are prevalent and relevant diseases due to their morbidity and mortality. The mechanism by which sleep apnea leads to coronary artery disease remains unclear. It is known that intermittent hypoxia, the main characteristic of sleep apnea, leads to inflammation and consequently may lead to endothelial dysfunction. Endothelial dysfunction precedes the development of atherosclerotic disease and the occurrence of cardiovascular events. Agents that potentially act to improve endothelial function may assist in the prevention of cardiovascular events. Patients using immunomodulators due to rheumatic diseases have a lower prevalence of cardiovascular diseases. However, the cardioprotective effect of these drugs in patients without autoimmune diseases is not known. Hydroxychloroquine (HCQ) is an immunomodulator used in the treatment of rheumatoid arthritis and systemic lupus erythematosus. In addition to its anti-inflammatory properties, HCQ reduces cholesterol and glycemia levels and has antithrombotic effects. The drug is inexpensive and widely available. The adverse effects of HCQ are rare and occur more frequently when using high doses.

Eligibility criteria: Inclusion Criteria:

* Apnea-Hypopnea index of 15 events/hour or higher

Exclusion Criteria:

* Contraindication for hydroxychloroquine (retinopathy, chronic liver disease, chronic renal disease)
* Rheumatologic disease

Primary outcomes:
measure: Change in endothelial function measured by peripheral artery tonometry in the reactive-hyperemia index (RHI) scale
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
measure: Change in endothelial function measured by flow-mediated dilation (%FMD-response)
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
Secondary outcomes:
measure: Change in fasting glucose blood levels (mg/dL)
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
measure: Change in glycosylated hemoglobin blood levels (%)
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
measure: Change in Lipidic profile
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
measure: Change in C-reactive protein (CRP) blood levels (mg/L)
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
measure: Change in neutrophils lymphocytes ratio (NLR)
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
measure: Change in Autonomic Nervous System
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
measure: Change in apnea/hypopnea index
timeFrame: before and after eight weeks of treatment with hydroxychloroquine
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Denis Martinez
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tedesco Silva LM, Cortes A, Rossi B, Boll L, Waclawovsky G, Eibel B, Cadaval Goncalves S, Irigoyen MC, Martinez D. Effects of Hydroxychloroquine on endOthelial function in eLDerly with sleep apnea (HOLD): study protocol for a randomized clinical trial. Trials. 2021 Sep 17;22(1):638. doi: 10.1186/s13063-021-05610-0.