Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Device: sham-CPAP; Device: active CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT00929175

07-020

Details and patient eligibility

About

Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.

Full description

This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP

Enrollment: 45 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of resistant hypertension
• Apnea/hypopnea index > 15

Exclusion criteria

• Cardiac surgery on last 3 months
• Serious arrhythmias
• Insulin dependent diabetes
• Debilitating neurological disease
• severe COPD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups

active CPAP

Active Comparator group

Description:

auto-PAP with therapeutic pressure

Treatment:

Device: active CPAP

sham-CPAP

Sham Comparator group

Description:

auto-PAP with pressure less than 1cm H2O

Treatment:

Device: sham-CPAP