A Phase 4 interventional study of Hydroxychloroquine and Placebo oral tablet in Cardiovascular Diseases, Endothelial Dysfunction and Sleep Apnea, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Status unknown at 1 site in Brazil. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Phase 4, Interventional, and Treatment
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
400mg/daily of hydroxychloroquine for 8 weeks
Drug: Hydroxychloroquine
Drug: Placebo oral tablet
400mg/daily of hydroxychloroquine for 8 weeks
Amido pills/daily for 8 weeks
Change in endothelial function measured by peripheral artery tonometry in the reactive-hyperemia index (RHI) scale
The reactive-hyperemia index (RHI) scale ranges from -0.4 to 1.6. Below -0.51 being endothelial dysfunction, a higher score indicates a better endothelial function
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in endothelial function measured by flow-mediated dilation (%FMD-response)
The FMD-response will be calculated as the variation in post-hyperaemia brachial artery diameter from baseline, measured in relative (percentage) change. A mean improvement in flow mediated dilatation of at least 2% would usually be required to detect a treatment benefit.
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in fasting glucose blood levels (mg/dL)
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in glycosylated hemoglobin blood levels (%)
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in Lipidic profile
Determined by total cholesterol, HDL-cholesterol and triglycerides blood levels (mg/dL)
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in C-reactive protein (CRP) blood levels (mg/L)
The risk of developing cardiovascular disease is quantified as follows: low: CRP level under 1.0 mg/L average: between 1.0 and 3.0 mg/L high: above 3.0 mg/L
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in neutrophils lymphocytes ratio (NLR)
calculated by dividing the number of neutrophils by number of lymphocytes. The mean range of healthy adult subjects is between 0.78 and 3.53.
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in Autonomic Nervous System
The data will be collected through the system of acquisition of pressure waves in a continuous and non-invasive way by the Finometer® system, through a cuffing installed in the middle finger, taking this signal to an analog-to-digital signal converter. The pulse pressure signal will be acquired at 1000 Hz, continuously and non-invasively, supine (10 minutes) in a quiet environment, with controlled temperature (± 23 ° C) and illumination. The collected data will be saved in the software BeatsScope® and LabChart®, from which will be extracted the systograms for analysis.
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Change in apnea/hypopnea index
Apnea/Hypopnea index is provided by home respiratory polygraphy, ranging from 0-highest events/hour, zero-5 eventos/hour being normal and above 5 events/hour being abnormal
Time frame: before and after eight weeks of treatment with hydroxychloroquine
Plan to share: No
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto de Cardiologia do Rio Grande do Sul