Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.
Condition: Obstructive Sleep Apnea; Hypertension; Cardiovascular Diseases
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Cardiovascular Diseases
Study type: Observational [Patient Registry]

Summary: 
      Evaluation of anthropometric, clinical and biological profile in four groups that represents
      transversely the natural history of Obstructive Sleep Apnea (OSA) and its associated
      cardiovascular comorbidities: non-OSA, OSA without hypertension, OSA and with hypertension
      and OSA with a cardiovascular event (CVE).
    

Detailed description: 
      Aims: The main objective of the study is to determine the risk profile associated with the
      development of cardiovascular (CV) disease in patients with OSA. To do this, by using genomic
      analysis tools, transcriptome and the analysis of protein markers are established the
      following objectives: 1) to determine differences in phenotypic profile (anthropometric,
      clinical, analytical and biological variables) from different populations: non-hypertensive
      patient with OSA, OSA hypertensive patient, OSA hypertensive patient who has developed a CV
      event and healthy subject. These four populations represent transversely the natural history
      of OSA. In this way the phenotype of the OSA patient and its relationship with risk of
      developing of CV disease will be defined. 2) To define the changes produced in these profiles
      after effective treatment with continuous positive airway pressure (CPAP). This approach
      allows to evaluate the different pathogenic pathways related to CV risk in patients with OSA.
      3) To define a predictive model of cardiovascular risk and response to CPAP treatment, in
      patients with OSA. 4) To phenotype and define the different and segregated clusters of OSA
      patients whose recognition may improve prognostic predictions and guide therapeutic
      strategies Methodology: For ethical reasons a longitudinal study cannot be carried out to
      know history natural the disease (can not leave without treatment patients with OSA long
      term). We propose a transversal study in which will be include four populations that
      representing transversally the natural history of OSA (non-OSA individuals, non-hypertensive
      OSA patients, OSA patients with hypertension and hypertensive OSA patients who have developed
      a CV event). All the patients will be performed a general analysis, lipid profile and
      polysomnography. The expression profile of microRNAs associated with cardiovascular risk will
      be assessed in addition to the gene expression profile associated with arterial hypertension.
      The measurements are made at baseline and 6 months after effective treatment with CPAP. This
      methodological approach will contribute in the identification of OSA phenotype which could
      develop cardiovascular disease.
    

Intervention name(s): Continuous Positive Airway Pressure
Intervention type(s): Device
Intervention description(s): Continuous Positive Airway Pressure
Other intervention name(s): CPAP
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Suspected OSA patients attending consecutively to the Sleep Unit of the University Hospital
        Arnau de Vilanova- Santa María de Lleida are included.
      
Biospecimen description: 
      Serum, Plasma and buffy coat
    
Keywords: miRNA; Cardiovascular Risk; CPAP; Obstructive Sleep Apnea; Hypertension; Molecular profile