Clinical trial NCT03513926: Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.
Official title: Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Hypertension
Cardiovascular Diseases
Keywords: miRNA
Cardiovascular Risk
CPAP
Obstructive Sleep Apnea
Hypertension
Molecular profile
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2018-05-02
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with suspected OSA that attend to Sleep Unit of Hospital Arnau de Vilanova- Santa Maria de Lleida.
* 18-60 years old

Exclusion Criteria:

* Any chronic disease (malignancy, renal insufficiency (glomerular filtration rate \<30 ml / min), severe chronic obstructive pulmonary disease, chronic depression and other chronic diseases very limiting),
* Any sleep disorder previously diagnosed: narcolepsy, insomnia, chronic lack of sleep, regular use of hypnotic or sedative drugs and restless leg syndrome
* Any genetic abnormality or disease
* Any medical, social or geographical factors which may endanger patient compliance. (For example, consumption of alcohol (more than 80 g / day in men and 60 g / day in women), disorientation, or a history of default).

Primary outcomes:
measure: Modeling the cardiovascular (CV) disease risk in patients with obstructive sleep apnea (OSA) through the analysis of the number and specific biomarkers.
timeFrame: Baseline
Secondary outcomes:
measure: Modeling the effect of the treatment with continuous positive airway pressure (CPAP) in patients with OSA with and without cardiovascular disease, through the analysis of the number and specific biomarkers.
timeFrame: After 6 months of follow-up
measure: Predictive model of cardiovascular risk
timeFrame: After 6 months of follow-up
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Universitario Santa Maria de Lleida
Study officials:
affiliation: Sociedad Española de Neumología y Cirugía Torácica
name: Ferran Barbé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Manuel Sanchez-de-la-Torre, PhD
role: PRINCIPAL_INVESTIGATOR
References: