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Anti-Inflammatory Drug and Endothelial Function (HOLD)

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ClinicalTrials.gov Identifier: NCT04161339
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Hospital de Clinicas de Porto Alegre
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Endothelial Dysfunction Sleep Apnea Atherosclerosis Coronary Artery Disease Drug: Hydroxychloroquine Drug: Placebo oral tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hydroxychloroquine on Endothelial Function: a Clinical Trial
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
400mg/daily of hydroxychloroquine for 8 weeks
Drug: Hydroxychloroquine
400mg/daily of hydroxychloroquine for 8 weeks

Placebo Comparator: Placebo Drug: Placebo oral tablet
Amido pills/daily for 8 weeks




Primary Outcome Measures :
  1. Change in endothelial function measured by peripheral artery tonometry in the reactive-hyperemia index (RHI) scale [ Time Frame: 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) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in fasting glucose blood levels (mg/dL) [ Time Frame: before and after eight weeks of treatment with hydroxychloroquine ]
  2. Change in glycosylated hemoglobin blood levels (%) [ Time Frame: before and after eight weeks of treatment with hydroxychloroquine ]
  3. Change in Lipidic profile [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161339


Contacts
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Contact: Maria Claudia Irigoyen 55 11 985589166 hipirigoyen@gmail.com
Contact: Leticia Maria Silva 55 51 993220727 tedescosilva.leticia@gmail.com

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
Contact: Andrea Rambo    +55 51 33598943      
Contact: Eloisa Medeiros    +55 51 33597604      
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Denis Martinez Federal University of Rio Grande do Sul

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Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT04161339    
Other Study ID Numbers: 5351/17
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Atherosclerosis
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents