Clinical trial NCT01508754: Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome
Official title: Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Syndrome
Resistant Hypertension
Keywords: Continuous positive airway pressure
Ambulatory blood pressures
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Financiadora de Estudos e Projetos
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-01-12
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive patients with moderate-severe obstructive sleep apnea syndrome (OSAS).

Detailed description: Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic BP despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory BPs in patients with resistant hypertension is largely unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as an apnea-hypopnea index \[AHI\] greater than 15 on a full polysomnographic examination). Two-hundred patients will be randomly allocated either to treatment with CPAP device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.

Eligibility criteria: Inclusion Criteria:

* Patients with resistant hypertension and moderate-severe obstructive sleep apnea syndrome

Exclusion Criteria:

* Older than 80 years
* Pregnant women
* Non-adherent to anti-hypertensive treatment
* Severe cognitive deficits

Primary outcomes:
measure: clinic and ambulatory blood pressures
timeFrame: 6 months
Secondary outcomes:
measure: Microalbuminuria
timeFrame: 6 months
measure: Aldosterone excess measurements
timeFrame: 6 months
measure: Arterial stiffness
timeFrame: 6 months
measure: Autonomic system measurements
timeFrame: 6 months
measure: Cardiorespiratory fitness
timeFrame: 6 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Program of Arterial Hypertension, University Hospital Clementino Fraga Filho
Study officials:
affiliation: Department of Internal Medicine, Faculty of Medicine, federal University of Rio de Janeiro
name: Gil F Salles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Duran-Cantolla J, Aizpuru F, Montserrat JM, Ballester E, Teran-Santos J, Aguirregomoscorta JI, Gonzalez M, Lloberes P, Masa JF, De La Pena M, Carrizo S, Mayos M, Barbe F; Spanish Sleep and Breathing Group. Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: randomised controlled trial. BMJ. 2010 Nov 24;341:c5991. doi: 10.1136/bmj.c5991.
citation: Lozano L, Tovar JL, Sampol G, Romero O, Jurado MJ, Segarra A, Espinel E, Rios J, Untoria MD, Lloberes P. Continuous positive airway pressure treatment in sleep apnea patients with resistant hypertension: a randomized, controlled trial. J Hypertens. 2010 Oct;28(10):2161-8. doi: 10.1097/HJH.0b013e32833b9c63.
citation: Cardoso CRL, Roderjan CN, Cavalcanti AH, Cortez AF, Muxfeldt ES, Salles GF. Effects of continuous positive airway pressure treatment on aortic stiffness in patients with resistant hypertension and obstructive sleep apnea: A randomized controlled trial. J Sleep Res. 2020 Aug;29(4):e12990. doi: 10.1111/jsr.12990. Epub 2020 Feb 12.
citation: de Souza F, Muxfeldt ES, Margallo V, Cortez AF, Cavalcanti AH, Salles GF. Effects of continuous positive airway pressure treatment on aldosterone excretion in patients with obstructive sleep apnoea and resistant hypertension: a randomized controlled trial. J Hypertens. 2017 Apr;35(4):837-844. doi: 10.1097/HJH.0000000000001254.
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