Cardiovascular Diseases Clinical Trial
Official title:
Phase 4 Study of the Relationship Between the Oxidative Stress and the Development of Cardiovascular Complications in the Sleep Apnea-hypopnea Syndrome (SAHS). Effect of the Treatment With CPAP
The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma
and condensed exhaled air between patients with SAHS and cardiovascular complications,
patients with SAHS without cardiovascular complications and control subjects. To evaluate
the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
Design: randomized, double blind, of parallel groups and controlled with placebo study.
Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without
cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23
control subjects.
Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo).
Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free
corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure,
endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1,
NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in
plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of
catecholamines.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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