About this trial
Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading modifiable contributor to cardiovascular disease and death. Our society has already identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of healthy living. Healthy sleep should be incorporated as the fourth pillar, as clearly supported by the extensively available scientific evidence. Targeting sleep is considered the new frontier in cardiovascular prevention. In fact, recent scientific evidence encourages consideration of including sleep disturbances in the top 10 potentially modifiable cardiovascular risk factors. Sleep-disordered breathing affect 30-80% of patients with hypertension. The personalized management of hypertension is challenging due to; i) the misclassification of hypertensive patients (affecting 1 out of 3 patients); ii) the lack of adequate treatment of high mortality risk hypertensive phenotypes today is an unmet clinical need; iii) unawareness of the impact of sleep-disordered breathing as a modifiable risk factor for hypertension. Importantly, the investigators already made the seminal observations showing that the treatment for sleep-disordered breathing reduces blood pressure in the hypertensive phenotypes with the highest mortality risk. Given the need for novel strategies to treat hypertension and, supported by our data, the investigators propose to study and treat sleep-disordered breathing to improve hypertension control. METASLEEP will go beyond current state-of the-art providing a new paradigm for the accurate hypertension classification and treatment. This project will open up a new avenue on the therapeutic potential of the management of sleep-disordered breathing in hypertension.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with arterial hypertension who visit their primary care physician in one of the participating primary care centers.
Signature of the informed consent.
Disqualifiers
Psycho-physical inability to complete questionnaires.
Patients with very limiting chronic disease.
Previous diagnosis of OSA or any other sleeping disorder
Active treatment with CPAP.
Trial population
Patients atttending to their primary care center for the control of their arterial hypertension.
Trial design
Cohort
Prospective
Treatments tested in this trial
CPAP or usual practice
DeviceCPAP (continuous positive airway pressure) is a machine that uses mild air pressure to keep breathing airways open while you sleep.
Monitoring and intervention in follow-up
DeviceEach participating center can incorporate monitoring and intervention in the follow-up of patients into their work dynamics. Through the use of mobile applications, you can monitor the variables of: weight, diet, lifestyle, exercise and sleep. This intervention will help the patient to improve in different aspects of their health.
Treatment groups
Trial outcomes
Primary outcomes
Changes in nocturnal blood pressure
Change in nocturnal blood pressure at 6 and 18 months with respect to baseline (mean night-time)
Secondary outcomes
Identification of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.
Identification a specific singular cluster of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.
Epigenetic, proteomic and metabolomic/lipidomic phenotype characterization
Characterization of the epigenetic, proteomic and metabolomic/lipidomic phenotype of hypertensive highly responders to CPAP treatment
Clinic phenotype characterization
Characterization of the clinic phenotype of hypertensive highly responders to CPAP treatment
Changes induced by exosomes
Changes in morphological, functional and molecular promoted by exosomes isolated from selected patients.
Sponsors and contacts
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Sociedad Española de Neumología y Cirugía Torácica
Lead sponsor
Instituto de Salud Carlos III
Collaborator