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

September 12, 2014 updated by: Gil Fernando da Costa Mendes de Salles, PhD, Universidade Federal do Rio de Janeiro

Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

125

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 de Janeiro, Brazil, 21941-913
        • Program of Arterial Hypertension, University Hospital Clementino Fraga Filho

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPAP
Treatment with Continuous Positive Airway Pressure
Procedure: Continuous positive airway pressure treatment
Treatment with CPAP for 6 months, pressure will be titrated during a second polysomnography.
No Intervention: Control
Usual anti-hypertensive treatment without CPAP treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinic and ambulatory blood pressures
Time Frame: 6 months
Clinic and ambulatory blood pressures (during 24-hour ambulatory blood pressure monitoring, which included both daytime and nighttime blood pressures, as well as the nocturnal dipping pattern).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microalbuminuria
Time Frame: 6 months
Urinary albumin excretion rate on 24-hour urine collection
6 months
Aldosterone excess measurements
Time Frame: 6 months
Serum aldosterone concentration, plasma renin activity, aldosterone-to-renin ratio and 24-hour urinary aldosterone excretion.
6 months
Arterial stiffness
Time Frame: 6 months
Carotid-femoral pulse wave velocity and aortic pulse wave contour analysis (which include aortic systolic and pulse pressure and augmentation index)
6 months
Autonomic system measurements
Time Frame: 6 months
Measures of autonomic system balance derived from 24-hour Holter monitoring, which includes heart rate variability on time and frequency domains.
6 months
Cardiorespiratory fitness
Time Frame: 6 months
Cardiorespiratory fitness by 6 min walking test with maximum oxigen consumption measurement and by complete ergospirometric treadmill test.
6 months

Collaborators and Investigators

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

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Financiadora de Estudos e Projetos
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Gil F Salles, PhD, Department of Internal Medicine, Faculty of Medicine, federal University of Rio de Janeiro

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

Helpful Links

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

January 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 12, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FINEP-01.08.0615.00

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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