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

Tracking Information
First Received Date ^ICMJE	June 9, 2009
Last Updated Date	April 20, 2011
Start Date ^ICMJE	February 2008
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2009)	Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00929175 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 25, 2009)	aldosterone, renin, activated protein C [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea
Official Title ^ICMJE	Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Resistant Hypertension
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: continuous positive airway pressure Intervention: Device: Continuous positive airway pressure Sham Comparator: CPAP device without positive pressure Intervention: Device: Continuous positive airway pressure
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	60
Completion Date	Not Provided
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT00929175
Other Study ID Numbers ^ICMJE	07-020
Has Data Monitoring Committee	Yes
Responsible Party	Flávio Danni Fuchs, Hospital de Clínicas de Porto Alegre
Study Sponsor ^ICMJE	Hospital de Clinicas de Porto Alegre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital de Clinicas de Porto Alegre
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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