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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Device: active CPAP; Device: sham-CPAP

• Registration Number: NCT00929175
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Detailed 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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active CPAP	active CPAP	auto-PAP with therapeutic pressure
sham-CPAP	sham-CPAP	auto-PAP with pressure less than 1cm H2O

Primary Outcome Measures

Name	Time	Method
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring	8 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
aldosterone, renin, activated protein C	8 weeks

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio grande do sul, Brazil