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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768807
• Other study ID #: ECOera-03
• Status: Completed
• Phase: N/A
• First received: October 6, 2008
• Last updated: May 4, 2012
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2012
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Apnea-hypopnea index higher than 5 events per hour

Exclusion Criteria:

• Body mass index higher than 40 kg/m2

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Ventricular Remodeling

Intervention

Device:
• CPAP (continuous positive airway pressure)
Patients treated by CPAP for 06 months

Locations

Country	Name	City	State
Brazil	Instituto do Sono/AFIP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of left ventricular diastolic echo variable		06 months	Yes