Anti-Inflammatory Drug and Endothelial Function (HOLD)

Instituto de Cardiologia do Rio Grande do Sul

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Endothelial Dysfunction; Sleep Apnea; Cardiovascular Diseases; Atherosclerosis

Treatments: Drug: Placebo oral tablet; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04161339

5351/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Hydroxychloroquine

Experimental group

Description:

400mg/daily of hydroxychloroquine for 8 weeks

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo oral tablet