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

Hypertension Clinical Trial

Official title: Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

• NCT number: NCT00929175
• Study type: Interventional
• Source: Hospital de Clinicas de Porto Alegre
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Completion date: April 2013