Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome
|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|
|Primary Completion Date :||August 2014|
|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.
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|