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NCT00570115 Clinical Trial

Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea

Sleep Apnea Syndromes Clinical Trial

Official title:
Left Atrial Volume and Function in Patients With Obstructive Sleep Apnea Assessed by Real Time Three Dimensional Echocardiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00570115
Other study ID # ecoera-001
Secondary ID
Status Completed
Phase N/A
First received December 7, 2007
Last updated May 7, 2012
Start date June 2007
Est. completion date November 2007

Study information
Verified date December 2007
Source Associação Fundo de Incentivo à Pesquisa
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional

Description:

Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- Age from 30 to 70

- Apnea-hypopnea index > 5 by polysomnography

Exclusion Criteria:

- Any cardiac disease

- Poor imaging quality by mean of echocardiography

- non-sinusal Rhythm

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Instituto do Sono/Federal University of Sao Paulo Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Anwar AM, Soliman OI, Geleijnse ML, Nemes A, Vletter WB, ten Cate FJ. Assessment of left atrial volume and function by real-time three-dimensional echocardiography. Int J Cardiol. 2008 Jan 11;123(2):155-61. Epub 2007 Apr 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Left Atrial enlargement 1 day No
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