Effects of Continuous Positive Airway Pressure (CPAP) in Patients With Resistant Hypertension and Obstructive Sleep Apnea (OSA)
Primary Purpose
Obstructive Sleep Apnea, Refractory Hypertension
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Refractory hypertension, Heart remodeling, Arterial stiffness, CPAP
Eligibility Criteria
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.
Sites / Locations
- Heart Institute (InCor)
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
1
2
Arm Description
CPAP
Outcomes
Primary Outcome Measures
Ambulatory blood pressure monitoring
Secondary Outcome Measures
Change from Baseline in Arterial stiffness at 6 months
change from baseline in heart remodeling at 6 months
Full Information
NCT ID
NCT00812695
First Posted
December 19, 2008
Last Updated
November 21, 2011
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00812695
Brief Title
Effects of Continuous Positive Airway Pressure (CPAP) in Patients With Resistant Hypertension and Obstructive Sleep Apnea (OSA)
Official Title
Effects of Continuous Positive Airway Pressure in Patients With Resistant Hypertension and Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Refractory hypertension Secondary causes of hypertension will be excluded using usual procedures from the Hypertension Unit.
Polysomnography All participants will be submitted to standard overnight polysomnography (EMBLA - Flagra hf. Medical Devices, Reykjavik, Iceland). The apnea-hypopnea index will be calculated as the total number of respiratory events (apneas plus hypopneas) per hour of sleep.
Apnea will be defined as an air flow cessation greater than 10 seconds and hypopnea as a reduction grater than 50% with oxygen saturation fall grater than 4% or arousal.
After recruitment, patients will be instructed about CPAP working by an experimented professional and another polysomnography will be done to adjust pressures. Hour counter will be used to check the adherence to CPAP.
Intervention Patients will be divided in two groups: medical treatment plus CPAP or medical treatment alone for 6 months without drug dose changing.
Twenty-four hour blood pressure monitoring Twenty-four hour blood pressure monitoring (system SpaceLabs 90207) will be used in all patients in the beginning and at the end of the study.
Arterial Stiffness Carotid-femoral arterial stiffness will be determined by Complior.
Echocardiography Echocardiography will be performed by using a commercially available machine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Refractory Hypertension
Keywords
Obstructive sleep apnea, Refractory hypertension, Heart remodeling, Arterial stiffness, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
CPAP
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Gold standard treatment for Obstructive sleep apnea
Primary Outcome Measure Information:
Title
Ambulatory blood pressure monitoring
Time Frame
Change from Baseline in Blood Pressure at 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Arterial stiffness at 6 months
Time Frame
baseline and 6 months
Title
change from baseline in heart remodeling at 6 months
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Heart Institute (InCor)
City
Sao Paulo
ZIP/Postal Code
05403-904
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23598607
Citation
Pedrosa RP, Drager LF, de Paula LKG, Amaro ACS, Bortolotto LA, Lorenzi-Filho G. Effects of OSA treatment on BP in patients with resistant hypertension: a randomized trial. Chest. 2013 Nov;144(5):1487-1494. doi: 10.1378/chest.13-0085.
Results Reference
derived
Learn more about this trial
Effects of Continuous Positive Airway Pressure (CPAP) in Patients With Resistant Hypertension and Obstructive Sleep Apnea (OSA)
We'll reach out to this number within 24 hrs