Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with arterial hypertension who visit their primary care physician in one of the participating primary care centers.

• Signature of the informed consent.

Locations
Other Locations
Spain
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Contact Information
Primary
Ferran Barbé Illa, MD
febarbe.lleida.ics@gencat.cat
+34 973705372
Backup
Manuel Sánchez de la Torre, PhD
manuel.sanchez@udl.cat
+34 973702959
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1523
Treatments
Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA
Patients with nocturnal hypertension and/or non-dipper pattern who undergo a sleep test, obtaining the diagnosis of obstructive sleep apnea, will be treated following the clinical practice standards.
Patients with nocturnal hypertension and/or non-dipper pattern and without OSA
Patients with nocturnal hypertension and/or non-dipper pattern undergoing a sleep test, the result of which is negative for obstructive sleep apnea disease.
Related Therapeutic Areas
Sponsors
Collaborators: Instituto de Salud Carlos III
Leads: Sociedad Española de Neumología y Cirugía Torácica

This content was sourced from clinicaltrials.gov