Long-term Cardiovascular Outcomes in Patients With RH and OSA With or Without Treatment With CPAP
SARAH
SARAH
Sponsor study identifier
observational
591
1 country
1
Study Start
April 29, 2016
Actual (reported)Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2016
Actual (reported)December 16, 2016
Actual (reported)December 23, 2016
Actual (reported)March 31, 2023
Actual (reported)March 31, 2023
Actual (reported)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
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
Patients without sleep apnoea
Patients with sleep apnoea who are treated (CPAP, surgery or MAD)
Patients with sleep apnoea who are not treated
Patients with Resistant Hypertension
Spanish Respiratory Society
Barcelona, Spain
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.
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.
* 2 tubes EDTA * 2 tubes with gel for serum * 1 tube for RNA extraction * 1 tube for urine
Ferran Barbé
Spanish Respiratory Society (SEPAR)
591 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2016
First Posted
December 23, 2016
Study Start
April 29, 2016
Actual (reported)Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Last Updated
November 22, 2023
Record last verified: 2023-11
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