Anti-Inflammatory Drug and Endothelial Function

NCT ID: NCT04161339

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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

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Cardiovascular Diseases Endothelial Dysfunction Sleep Apnea Atherosclerosis Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydroxychloroquine

400mg/daily of hydroxychloroquine for 8 weeks

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

400mg/daily of hydroxychloroquine for 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Amido pills/daily for 8 weeks

Interventions

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Hydroxychloroquine

400mg/daily of hydroxychloroquine for 8 weeks

Intervention Type DRUG

Placebo oral tablet

Amido pills/daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role collaborator

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis Martinez

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Maria Claudia Irigoyen

Role: CONTACT

55 11 985589166

Leticia Maria Silva

Role: CONTACT

55 51 993220727

Facility Contacts

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Andrea Rambo

Role: primary

+55 51 33598943

Eloisa Medeiros

Role: backup

+55 51 33597604

References

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Tedesco Silva LM, Cortes A, Rossi B, Boll L, Waclawovsky G, Eibel B, Cadaval Goncalves S, Irigoyen MC, Martinez D. Effects of Hydroxychloroquine on endOthelial function in eLDerly with sleep apnea (HOLD): study protocol for a randomized clinical trial. Trials. 2021 Sep 17;22(1):638. doi: 10.1186/s13063-021-05610-0.

Reference Type DERIVED
PMID: 34535165 (View on PubMed)

Other Identifiers

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5351/17

Identifier Type: -

Identifier Source: org_study_id

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