NCT04161339

Anti-Inflammatory Drug and Endothelial Function

Effect of Hydroxychloroquine on Endothelial Function: a Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Instituto de Cardiologia do Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Endothelial Dysfunction
• Sleep Apnea
• Atherosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	400mg/daily of hydroxychloroquine for 8 weeks
DRUG	Placebo oral tablet	Amido pills/daily for 8 weeks

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-11-13
• Last updated: 2019-11-13

Locations

1 site across 1 country: Brazil