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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513926
• Other study ID #: PI14/01266
• Status: Completed
• Start date: November 2014
• Est. completion date: September 2018

Study information

• Verified date: April 2019
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: September 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Diseases
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
Continuous Positive Airway Pressure

Locations

Country	Name	City	State
Spain	Hospital Universitario Santa Maria de Lleida	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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