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

NCT ID: NCT03002558

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 591 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-29
• Study Completion Date: 2023-03-31

Brief 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.

Detailed Description

A minimum follow-up of 5 years has been established. During the follow-up, an annually programmed visit will be carried on to all patients, collecting variables from subjects' interview in the office.The baseline and follow-up variables will be collected using questionnaires.

The variables that will be collected are:

BP variables; Anthropometric variables; Compliance with CPAP in the case of CPAP-treated OSA patients; blood samples extraction; outcomes (heart disease, cerebrovascular disease, kidney disease, vascular disease). All the cardiovascular events will be independently evaluated by two doctors to establish a diagnostic. In case of discordance a third external doctor will assess the case. The date of each event will be recorded.

Conditions

Hypertension

Study Design

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

Study Groups

control (non-OSA)

Patients without sleep apnoea

No interventions assigned to this group

OSA-treated

Patients with sleep apnoea who are treated (CPAP, surgery or MAD)

No interventions assigned to this group

OSA-non treated

Patients with sleep apnoea who are not treated

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed of RH according to the following criteria, which include 2 clinical situations: (i) BP above control in ABPM (24-h BP > 130/80 mmHg),regardless of optimal dose treatment with 3 agents (one must be a diuretic). Other causes of inadequate control must be discarded (poor compliance, drugs). (ii) Controlled BP but treated with no less than 4 medications.
• Patients aged 18 to 75 years old.
• To sign informed consent for the participation in the study.

Exclusion Criteria

• Secondary hypertension to endocrinology causes (pheochromocytoma, Conn disease, Cushing´s Syndrome, hyperparathyroidism), drug treatment (NSAID or cortisone, immunodepressants, EPO), renal artery stenosis, alcohol abuse, aortic coarctation and intracranial tumours.
• Any process, that limits life expectancy to less than one year.
• Previously diagnosed OSA with current active treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Ferran Barbe

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferran Barbé

Role: PRINCIPAL_INVESTIGATOR

Spanish Respiratory Society (SEPAR)

Locations

Spanish Respiratory Society

Barcelona, , Spain

Countries

Spain

References

Sapina-Beltran E, Benitez ID, Torres G, Fortuna-Gutierrez AM, Ponte Marquez P, Masa JF, Drager LF, Cabrini M, Felez M, Vazquez S, Abad J, Lee C, Garcia-Rio F, Casitas R, Mediano O, Romero Peralta S, Martinez D, Sanchez-de-la-Torre M, Barbe F, Dalmases M. Effect of CPAP treatment on BP in resistant hypertensive patients according to the BP dipping pattern and the presence of nocturnal hypertension. Hypertens Res. 2022 Mar;45(3):436-444. doi: 10.1038/s41440-021-00762-7. Epub 2021 Dec 24.

Reference Type: DERIVED

PMID: 34952953 (View on PubMed)

Sapina-Beltran E, Torres G, Benitez I, Fortuna-Gutierrez AM, Marquez PP, Masa JF, Corral-Penafiel J, Drager LF, Cabrini M, Felez M, Vazquez S, Abad J, Lee CH, Aung AT, Garcia-Rio F, Casitas R, Sanchez-de-la-Torre M, Gaeta AM, Barbe F, Dalmases M. Prevalence, Characteristics, and Association of Obstructive Sleep Apnea with Blood Pressure Control in Patients with Resistant Hypertension. Ann Am Thorac Soc. 2019 Nov;16(11):1414-1421. doi: 10.1513/AnnalsATS.201901-053OC.

Reference Type: DERIVED

PMID: 31514508 (View on PubMed)

Other Identifiers

SARAH-1

Identifier Type: -

Identifier Source: org_study_id