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Long-term Cardiovascular Outcomes in Patients With RH and OSA With or Without Treatment With CPAP

NCT03002558 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 591

Last updated 2023-11-22

No results posted yet for this study

Summary

Objectives:

Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension (RH).

Secondary objectives: i) to identify the subclinical organ damage profile at baseline and its association with OSA, and to identify if long term blood pressure control and number of antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii) to identify epigenetic profiles and clinical, biological and polygraphic variables with a predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA diagnosis and treatment in patients with RH.

Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and subclinical organ damage variables and biological samples at baseline will be collected from all the subjects included. A sleep study will be performed in all the subjects at the study inclusion date. Subsequently, the OSA subjects will be managed as per local standard practice. Follow-up variables will be annually collected (including blood samples). On the basis of OSA and its treatment, three cohorts of RH subjects will be defined: control (non-OSA), OSA-treated and OSA nontreated.

Conditions

Sponsors & Collaborators

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • ResMed

    collaborator INDUSTRY

  • Sociedad Española de Neumología y Cirugía Torácica

    lead OTHER

Principal Investigators

  • Ferran Barbé · Spanish Respiratory Society (SEPAR)

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-29
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002558 on ClinicalTrials.gov