Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome
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|ClinicalTrials.gov Identifier: NCT01508754|
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : September 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Syndrome Resistant Hypertension||Procedure: Continuous positive airway pressure treatment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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
- 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).
- Microalbuminuria [ Time Frame: 6 months ]Urinary albumin excretion rate on 24-hour urine collection
- Aldosterone excess measurements [ Time Frame: 6 months ]Serum aldosterone concentration, plasma renin activity, aldosterone-to-renin ratio and 24-hour urinary aldosterone excretion.
- 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)
- 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.
- Cardiorespiratory fitness [ Time Frame: 6 months ]Cardiorespiratory fitness by 6 min walking test with maximum oxigen consumption measurement and by complete ergospirometric treadmill test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508754
|Program of Arterial Hypertension, University Hospital Clementino Fraga Filho|
|Rio de Janeiro, Brazil, 21941-913|
|Principal Investigator:||Gil F Salles, PhD||Department of Internal Medicine, Faculty of Medicine, federal University of Rio de Janeiro|