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

Universidade Federal do Rio de Janeiro

Status and phase: Completed; Phase 4

Conditions: Resistant Hypertension; Obstructive Sleep Apnea Syndrome

Treatments: Procedure: Continuous positive airway pressure treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01508754

FINEP-01.08.0615.00

Details and patient eligibility

About

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).

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

CPAP

Active Comparator group

Description:

Treatment with Continuous Positive Airway Pressure

Treatment:

Procedure: Continuous positive airway pressure treatment

Control

No Intervention group

Description:

Usual anti-hypertensive treatment without CPAP treatment