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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Universidade Federal do Rio de Janeiro.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Financiadora de Estudos e Projetos (FINEP - Brasil)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Gil Fernando da Costa Mendes de Salles, PhD, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01508754
First received: January 5, 2012
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
Resistant Hypertension
Procedure: Continuous positive airway pressure treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • clinic and ambulatory blood pressures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Microalbuminuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Urinary albumin excretion rate on 24-hour urine collection

  • Aldosterone excess measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Serum aldosterone concentration, plasma renin activity, aldosterone-to-renin ratio and 24-hour urinary aldosterone excretion.

  • Arterial stiffness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Carotid-femoral pulse wave velocity and aortic pulse wave contour analysis (which include aortic systolic and pulse pressure and augmentation index)

  • Autonomic system measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measures of autonomic system balance derived from 24-hour Holter monitoring, which includes heart rate variability on time and frequency domains.

  • Cardiorespiratory fitness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cardiorespiratory fitness by 6 min walking test with maximum oxigen consumption measurement and by complete ergospirometric treadmill test.


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508754

Contacts
Contact: Gil F Salles, PhD 55-21-25622514 gilsalles@hucff.ufrj.br
Contact: Elizabeth S Muxfeldt, PhD 55-21-25622513 bethmux@globo.com

Locations
Brazil
Program of Arterial Hypertension, University Hospital Clementino Fraga Filho Recruiting
Rio de Janeiro, Brazil, 21941-913
Principal Investigator: Gil F Salles, PhD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Financiadora de Estudos e Projetos (FINEP - Brasil)
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
  More Information

Additional Information:
Publications:

Responsible Party: Gil Fernando da Costa Mendes de Salles, PhD, Full Professor, Faculty of Medicine, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01508754     History of Changes
Other Study ID Numbers: FINEP-01.08.0615.00
Study First Received: January 5, 2012
Last Updated: January 9, 2012
Health Authority: Brazil: Ministry of Health
Brazil: Ministry of Science and Technology

Keywords provided by Universidade Federal do Rio de Janeiro:
Continuous positive airway pressure
Ambulatory blood pressures

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014