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NCT Number: NCT03002558

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

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.

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Key information

Conditions

Hypertension Apnea Cardiovascular Diseases Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spanish Respiratory Society

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation the impact of OSA and its treatment on cardiovascular outcomes

    Time frame: After 5 years of follow-up

    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.

Secondary outcomes

  1. 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.

    Time frame: After 5 years of follow-up

    It will be evaluated cardiovascular outcomes at the end of the study. These outcomes will be collected from subjects' interviews at each yearly follow-up visit in the office and from computed medical records.

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

    Time frame: After 5 years of follow-up

    Using DNA and RNA samples, it will be performed different analysis at the end of the study, to see if there is any change in genes related to both diseases

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

    Time frame: 2 years

    Analyse mRNA to validate de HIPARCO score

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

    Time frame: 3 years

    Identify a plasma miRNA profile that predicts blood pressure response to CPAP treatment.

  5. 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.

    Time frame: After 5 years of follow-up

    Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Collaborators

  • Fondo de Investigacion Sanitaria
  • ResMed

Registry information

Official study title

Long-term Cardiovascular Outcomes in Patients With Resistant Hypertension and Obstructive Sleep Apnea With or Without Treatment With Continuous Positive Airway Pressure.

Acronym: SARAH

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2016
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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