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

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Obstructive Sleep Apnea
• Intervention / Treatment: Device: Continuous Positive Airway Pressure

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.

• Study Type: Observational
• Enrollment (Actual): 338

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25198
    • Hospital Universitario Santa Maria de Lleida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-OSA group; Patients with out sleep apnea.
OSA group; Patients with OSA, without cardiovascular comorbidities who could be treated with Continuous Positive Airway Pressure	Device: Continuous Positive Airway Pressure; Continuous Positive Airway Pressure; Other Names: CPAP
OSA with hypertension group; Patients with OSA, with hypertension who could be treated with Continuous Positive Airway Pressure	Device: Continuous Positive Airway Pressure; Continuous Positive Airway Pressure; Other Names: CPAP
OSA with CVE group; Patients with OSA, with a previous ictus or stroke who could be treated with Continuous Positive Airway Pressure	Device: Continuous Positive Airway Pressure; Continuous Positive Airway Pressure; Other Names: CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modeling the cardiovascular (CV) disease risk in patients with obstructive sleep apnea (OSA) through the analysis of the number and specific biomarkers.	Anthropometric, clinical, analytical and biological variables characterization from different populations:non-OSA, OSA without hypertension, OSA with hypertension and OSA with a CV event. The evaluation of these variables will permit the characterization of the profile associated with CV disease in patients with OSA.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Anthropometric, clinical, analytical and biological variables characterization from different populations:non-OSA, OSA without hypertension, OSA with hypertension and OSA with a CV event. The evaluation of these variables changes after CPAP treatment will allow to characterize the effect of this treatment in biomarker related with CV disease	After 6 months of follow-up
Predictive model of cardiovascular risk	Define a predictive model of cardiovascular risk and response to CPAP treatment, in patients with OSA.	After 6 months of follow-up

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Collaborators: Fondo de Investigacion Sanitaria
• Investigators: Principal Investigator: Ferran Barbé, MD, Sociedad Española de Neumología y Cirugía Torácica; Principal Investigator: Manuel Sanchez-de-la-Torre, PhD, Consorcio Centro de Investigación Biomédica en Red, M.P.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Hypertension; Obstructive Sleep Apnea; miRNA; CPAP; Cardiovascular Risk; Molecular profile
• Additional Relevant MeSH Terms: Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Cardiovascular Diseases; Apnea
• Other Study ID Numbers: PI14/01266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No