Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.

NCT ID: NCT03513926

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 338 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-09-30

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.

Conditions

Obstructive Sleep Apnea; Hypertension; Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Non-OSA group

Patients with out sleep apnea.

No interventions assigned to this group

OSA group

Patients with OSA, without cardiovascular comorbidities who could be treated with Continuous Positive Airway Pressure

Continuous Positive Airway Pressure

Intervention Type: DEVICE

Continuous Positive Airway Pressure

OSA with hypertension group

Patients with OSA, with hypertension who could be treated with Continuous Positive Airway Pressure

Continuous Positive Airway Pressure

Intervention Type: DEVICE

Continuous Positive Airway Pressure

OSA with CVE group

Patients with OSA, with a previous ictus or stroke who could be treated with Continuous Positive Airway Pressure

Continuous Positive Airway Pressure

Intervention Type: DEVICE

Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure

Continuous Positive Airway Pressure

Intervention Type: DEVICE

Other Intervention Names

CPAP

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Ferran Barbe

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferran Barbé, MD

Role: PRINCIPAL_INVESTIGATOR

Sociedad Española de Neumología y Cirugía Torácica

Manuel Sanchez-de-la-Torre, PhD

Role: PRINCIPAL_INVESTIGATOR

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Locations

Hospital Universitario Santa Maria de Lleida

Lleida, , Spain

Countries

Spain

Other Identifiers

PI14/01266

Identifier Type: -

Identifier Source: org_study_id