NCT01508754

Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome

Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea Syndrome
• Resistant Hypertension

Interventions

Type	Name	Description
PROCEDURE	Continuous positive airway pressure treatment	Treatment with CPAP for 6 months, pressure will be titrated during a second polysomnography.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-01-12
• Last updated: 2014-09-15

Locations

1 site across 1 country: Brazil