Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
active CPAP
sham-CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Resistant Hypertension, Sleep apnea syndrome, Treatment
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of resistant hypertension
- Apnea/hypopnea index > 15
Exclusion Criteria:
- Cardiac surgery on last 3 months
- Serious arrhythmias
- Insulin dependent diabetes
- Debilitating neurological disease
- severe COPD
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active CPAP
sham-CPAP
Arm Description
auto-PAP with therapeutic pressure
auto-PAP with pressure less than 1cm H2O
Outcomes
Primary Outcome Measures
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring
Secondary Outcome Measures
aldosterone, renin, activated protein C
Full Information
NCT ID
NCT00929175
First Posted
June 9, 2009
Last Updated
February 24, 2014
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00929175
Brief Title
Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
Official Title
Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.
Detailed Description
This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Resistant Hypertension, Sleep apnea syndrome, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active CPAP
Arm Type
Active Comparator
Arm Description
auto-PAP with therapeutic pressure
Arm Title
sham-CPAP
Arm Type
Sham Comparator
Arm Description
auto-PAP with pressure less than 1cm H2O
Intervention Type
Device
Intervention Name(s)
active CPAP
Intervention Description
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
Intervention Type
Device
Intervention Name(s)
sham-CPAP
Intervention Description
The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O.
Primary Outcome Measure Information:
Title
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring
Time Frame
8 weeks after treatment
Secondary Outcome Measure Information:
Title
aldosterone, renin, activated protein C
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of resistant hypertension
Apnea/hypopnea index > 15
Exclusion Criteria:
Cardiac surgery on last 3 months
Serious arrhythmias
Insulin dependent diabetes
Debilitating neurological disease
severe COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio D Fuchs
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio grande do sul
ZIP/Postal Code
90035003
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
25084263
Citation
de Oliveira AC, Martinez D, Massierer D, Gus M, Goncalves SC, Ghizzoni F, Steinhorst AM, Moreira LB, Fuchs SC, Fuchs FD. The antihypertensive effect of positive airway pressure on resistant hypertension of patients with obstructive sleep apnea: a randomized, double-blind, clinical trial. Am J Respir Crit Care Med. 2014 Aug 1;190(3):345-7. doi: 10.1164/rccm.201403-0479LE. No abstract available.
Results Reference
derived
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Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
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