Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea

NCT ID: NCT00768807

Last Updated: 2012-05-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.

Detailed Description

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Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sham CPAP

Patients submitted to SHAM CPAP use for 06 months

Group Type SHAM_COMPARATOR

CPAP (continuous positive airway pressure)

Intervention Type DEVICE

Patients treated by CPAP for 06 months

CPAP

OSA patients submitted to 06 months of CPAP treatment

Group Type ACTIVE_COMPARATOR

CPAP (continuous positive airway pressure)

Intervention Type DEVICE

Patients treated by CPAP for 06 months

Interventions

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CPAP (continuous positive airway pressure)

Patients treated by CPAP for 06 months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Apnea-hypopnea index higher than 5 events per hour

Exclusion Criteria

* Body mass index higher than 40 kg/m2
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role lead

Responsible Party

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Wercules Antonio Alves de Oliveira

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto do Sono/AFIP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Oliveira W, Campos O, Cintra F, Matos L, Vieira ML, Rollim B, Fujita L, Tufik S, Poyares D. Impact of continuous positive airway pressure treatment on left atrial volume and function in patients with obstructive sleep apnoea assessed by real-time three-dimensional echocardiography. Heart. 2009 Nov;95(22):1872-8. doi: 10.1136/hrt.2009.173625. Epub 2009 Jul 29.

Reference Type DERIVED
PMID: 19643769 (View on PubMed)

Other Identifiers

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ECOera-03

Identifier Type: -

Identifier Source: org_study_id

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