Effects of Continuous Positive Airway Pressure in Patients With Resistant Hypertension and Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Ambulatory blood pressure monitoring
Study Overview
Brief Summary
Obstructive sleep apnea (OSA) is an important cause of refractory hypertension but the impact of treatment with continuous positive airway pressure (CPAP) is not completely understood. The aim of this project is to study the effects of CPAP on blood pressure control and its influences on cardiac remodeling and arterial stiffness in patients with refractory hypertension and moderate or severe OSA.
Detailed Description
Study design Interventional, open-label, randomized.
Patients selection
Fifty refractory hypertensive patients with moderate-to-severe OSA, aged between 30 to 65 years old will be recruited from the outpatient clinics of the Heart Institute by the hospital staff.
Refractory hypertension will be defined as usually: blood pressure higher than or equal to 140x90 mmHg after a regimen of three drugs, including a diuretic for a minimum of 3 months. Initial evaluation will consist on ambulatory blood pressure measurement for 24 hours and a detailed clinical examination. Moderate to severe OSA will be defined as an apnea-hypopnea index > 15 evens per hour, after an overnight polysomnography.
Exclusion criteria include BMI >40 kg/m2; diabetes mellitus; aortic, heart and valve diseases; renal failure; other identifiable causes of hypertension, no adherence, use of cocaine, amphetamines, other illicit drugs, sympathomimetics (decongestants, anorectics), oral contraceptive hormones, nonsteroidal anti-inflammatory drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Refractory hypertensive patients with moderate-to-severe OSA, aged between 30 to 65 years old.
Exclusion Criteria
- •Aortic, heart and valve diseases
- •Renal failure
- •Other identifiable causes of hypertension, no adherence, use of cocaine, amphetamines, other illicit drugs, sympathomimetics (decongestants, anorectics), oral contraceptive hormones, nonsteroidal anti-inflammatory drugs.
Arms & Interventions
1
2
CPAP
Intervention: CPAP (Device)
Outcomes
Primary Outcomes
Ambulatory blood pressure monitoring
Time Frame: Change from Baseline in Blood Pressure at 6 months
Secondary Outcomes
- Change from Baseline in Arterial stiffness at 6 months(baseline and 6 months)
- change from baseline in heart remodeling at 6 months(baseline and 6 months)
Investigators
Geraldo Lorenzi-Filho
MD; PhD
University of Sao Paulo