NCT04161339

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_4 cardiovascular-diseases

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_4 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 13, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 29, 2019

Last Update Submit

November 11, 2019

Conditions

Cardiovascular DiseasesEndothelial DysfunctionSleep ApneaAtherosclerosisCoronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    before and after eight weeks of treatment with hydroxychloroquine

Secondary Outcomes (7)

  • Change in fasting glucose blood levels (mg/dL)

    before and after eight weeks of treatment with hydroxychloroquine

  • Change in glycosylated hemoglobin blood levels (%)

    before and after eight weeks of treatment with hydroxychloroquine

  • Change in Lipidic profile

    before and after eight weeks of treatment with hydroxychloroquine

  • Change in C-reactive protein (CRP) blood levels (mg/L)

    before and after eight weeks of treatment with hydroxychloroquine

  • Change in neutrophils lymphocytes ratio (NLR)

    before and after eight weeks of treatment with hydroxychloroquine

  • +2 more secondary outcomes

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

400mg/daily of hydroxychloroquine for 8 weeks

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR
Drug: Placebo oral tablet

Interventions

HydroxychloroquineDRUG

400mg/daily of hydroxychloroquine for 8 weeks

Hydroxychloroquine
Placebo oral tabletDRUG

Amido pills/daily for 8 weeks

Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apnea-Hypopnea index of 15 events/hour or higher

You may not qualify if:

  • Contraindication for hydroxychloroquine (retinopathy, chronic liver disease, chronic renal disease)
  • Rheumatologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34535165DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesSleep Apnea SyndromesAtherosclerosisCoronary Artery Disease

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Denis Martinez

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Claudia Irigoyen

CONTACT

55 11 985589166hipirigoyen@gmail.com

Leticia Maria Silva

CONTACT

55 51 993220727tedescosilva.leticia@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2019

First Posted

November 13, 2019

Study Start

July 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

November 13, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)