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

February 24, 2014 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio grande do sul
      • Porto Alegre, Rio grande do sul, Brazil, 90035003
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active CPAP
auto-PAP with therapeutic pressure
Device: active CPAP
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
Sham Comparator: sham-CPAP
auto-PAP with pressure less than 1cm H2O
Device: sham-CPAP
The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring
Time Frame: 8 weeks after treatment
8 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
aldosterone, renin, activated protein C
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Flavio D Fuchs, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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