Obstructive Sleep Apnea Clinical Trial
— OSA-MRIOfficial title:
Effects of Continuous Positive Airway Pressure on Heart Remodeling in Patients With Obstructive Sleep Apnea: A Randomized Study With Cardiovascular Magnetic Resonance Imaging
Verified date | November 2014 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
Obstructive sleep apnea (OSA) is independently associated with important heart remodeling that further contributes to overt heart failure. Recent evidences using echocardiogram suggested that continuous positive airway pressure (CPAP) has beneficial effects mainly on left ventricle parameters. However, the evidences regarding the right ventricle are scanty. In addition, no previous studies evaluated morphological and functional characteristics in OSA by magnetic resonance imaging (MRI) as well as the impact of CPAP.
Status | Terminated |
Enrollment | 24 |
Est. completion date | December 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients free of comorbidities with severe Obstructive Sleep Apnea by polysomnography. - Healthy volunteers (no obstructive sleep apnea and no comorbidities) matched for age, sex and body mass index. Exclusion Criteria: - Subjects older than 60 years - Body mass index (BMI) >40 kg/m2 - Diabetes mellitus - Hypertension - Cerebrovascular disease - Valvular heart disease - Renal failure - Current or past smoking history - Chronic use of any medication |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Heart Institute (InCor) | Sao Paulo | |
Brazil | Heart Institute (InCor) - University of São Paulo Medical School | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Right ventricle parameters: size and function. | Baseline and after 3 months. | No | |
Secondary | Left Ventricle parameters: size and function | Baseline and after 3 months. | No |
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