Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea Syndrome
- Sponsor
- Universidade Federal do Rio de Janeiro
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- clinic and ambulatory blood pressures
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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).
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.
Investigators
Gil Fernando da Costa Mendes de Salles, PhD
Full Professor, Faculty of Medicine
Universidade Federal do Rio de Janeiro
Eligibility 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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Arterial stiffness(6 months)
- Aldosterone excess measurements(6 months)
- Autonomic system measurements(6 months)
- Cardiorespiratory fitness(6 months)
- Microalbuminuria(6 months)