Anti-Inflammatory Drug and Endothelial Function

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StatusVrbovanje

Sponzori

Instituto de Cardiologia do Rio Grande do Sul

Suradnici

Hospital de Clinicas de Porto Alegre

KLINIČKO ISPITIVANJE: NCT04161339

BioSeek: NCT04161339

Ključne riječi

Sažetak

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.

Opis

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.

Datumi

Posljednja provjera:	09/30/2019
Prvo podneseno:	10/28/2019
Predviđena prijava poslana:	11/10/2019
Prvo objavljeno:	11/12/2019
Posljednje ažuriranje poslano:	11/10/2019
Posljednje ažuriranje objavljeno:	11/12/2019
Stvarni datum početka studija:	06/30/2019
Procijenjeni datum primarnog završetka:	06/29/2020
Procijenjeni datum završetka studije:	06/29/2020

Stanje ili bolest

Cardiovascular Diseases

Endothelial Dysfunction

Sleep Apnea

Atherosclerosis

Coronary Artery Disease

Intervencija / liječenje

Drug: Hydroxychloroquine

Drug: Placebo

Faza

Faza 4

Grupe ruku

Ruka	Intervencija / liječenje
Experimental: Hydroxychloroquine 400mg/daily of hydroxychloroquine for 8 weeks	Drug: Hydroxychloroquine 400mg/daily of hydroxychloroquine for 8 weeks
Placebo Comparator: Placebo	Drug: Placebo Amido pills/daily for 8 weeks

Kriterij prihvatljivosti

Dobni uvjeti za studiranje	60 Years Do 60 Years
Spolovi koji ispunjavaju uvjete za studij	All
Prihvaća zdrave volontere	Da
Kriteriji	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

Ishod

Primarne mjere ishoda

1. Change in endothelial function measured by peripheral artery tonometry in the reactive-hyperemia index (RHI) scale [before and after eight weeks of treatment with hydroxychloroquine]

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

2. Change in endothelial function measured by flow-mediated dilation (%FMD-response) [before and after eight weeks of treatment with hydroxychloroquine]

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.

Sekundarne mjere ishoda

1. Change in fasting glucose blood levels (mg/dL) [before and after eight weeks of treatment with hydroxychloroquine]

2. Change in glycosylated hemoglobin blood levels (%) [before and after eight weeks of treatment with hydroxychloroquine]

3. Change in Lipidic profile [before and after eight weeks of treatment with hydroxychloroquine]

Determined by total cholesterol, HDL-cholesterol and triglycerides blood levels (mg/dL)

4. Change in C-reactive protein (CRP) blood levels (mg/L) [before and after eight weeks of treatment with hydroxychloroquine]

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

5. Change in neutrophils lymphocytes ratio (NLR) [before and after eight weeks of treatment with hydroxychloroquine]

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.

6. Change in Autonomic Nervous System [before and after eight weeks of treatment with hydroxychloroquine]

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.

7. Change in apnea/hypopnea index [before and after eight weeks of treatment with hydroxychloroquine]

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

Anti-Inflammatory Drug and Endothelial Function

Ključne riječi

hypoxia

upala

reuma

arthritis

coronary artery disease

protuupalno