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

NCT03002558 | Completed DMC

• 1 other identifier: SARAH-1
• Study Type: observational
• Target: 591
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Continuous Positive Airway Pressure; Obstructive Sleep Apnea; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Evaluation the impact of OSA and its treatment on cardiovascular outcomes

  OSA diagnosis shall be established by PSG or PCR. It will be evaluated cardiovascular outcomes (CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure and new hospitalization for unstable angina or Transitory Ischemic Attack) before and after of OSA diagnosis and treatment.

  After 5 years of follow-up

Secondary Outcomes (5)

• Cardiovascular composite: CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure and new hospitalization for unstable angina or Transitory Ischemic Attack.

  After 5 years of follow-up

• Identify epigenetic biomarkers signatures with a predictive value of favourable cardiovascular outcome in patients with RH.

  After 5 years of follow-up

• Validation the HIPARCO - Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)

  2 years

• Creation of a predictive tool (like HIPARCO-Score) for women

  3 years

• Cost- Effectiveness analyses between study groups and to compare the cost of health care utilization between two year before and after the starting of the study related to the study groups.

  After 5 years of follow-up

Study Arms (3)

control (non-OSA)

Patients without sleep apnoea

OSA-treated

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

OSA-non treated

Patients with sleep apnoea who are not treated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Resistant Hypertension

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Fondo de Investigacion Sanitaria: collaborator
• ResMed: collaborator

Study Sites (1)

Spanish Respiratory Society

Barcelona, Spain

Location

Related Publications (2)

• 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.

  PMID: 34952953 DERIVED

• 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.

  PMID: 31514508 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* 2 tubes EDTA * 2 tubes with gel for serum * 1 tube for RNA extraction * 1 tube for urine

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ferran Barbé

  Spanish Respiratory Society (SEPAR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 23, 2016
• Study Start: April 29, 2016
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

ES (1)