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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00929175
First received: June 9, 2009
Last updated: April 20, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Resistant Hypertension
 Device: Continuous positive airway pressure
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • aldosterone, renin, activated protein C [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: continuous positive airway pressure Device: Continuous positive airway pressure
After randomization, one group wil be treated with therapeutic pressure CPAP and another group will be treated with subtherapeutic pressure CPAP for 8 weeks.
Sham Comparator: CPAP device without positive pressure Device: Continuous positive airway pressure
After randomization, one group wil be treated with therapeutic pressure CPAP and another group will be treated with subtherapeutic pressure CPAP for 8 weeks.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929175

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio grande do sul, Brazil, 90035003
Contact: Ana Claudia T Oliveira, physician     (55) 51 81594114     anactonelli@yahoo.com.br    
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
  More Information

No publications provided

Responsible Party: Flávio Danni Fuchs, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00929175     History of Changes
Other Study ID Numbers: 07-020
Study First Received: June 9, 2009
Last Updated: April 20, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Hypertension
Resistant Hypertension
Sleep apnea syndrome
Treatment

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013