Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hypertension
Started Feb 2008
Longer than P75 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFebruary 25, 2014
April 1, 2013
5.2 years
June 9, 2009
February 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring
8 weeks after treatment
Secondary Outcomes (1)
aldosterone, renin, activated protein C
8 weeks
Study Arms (2)
active CPAP
ACTIVE COMPARATORauto-PAP with therapeutic pressure
sham-CPAP
SHAM COMPARATORauto-PAP with pressure less than 1cm H2O
Interventions
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of resistant hypertension
- Apnea/hypopnea index \> 15
You may not qualify if:
- Cardiac surgery on last 3 months
- Serious arrhythmias
- Insulin dependent diabetes
- Debilitating neurological disease
- severe COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003, Brazil
Related Publications (1)
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.
PMID: 25084263DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Flavio D Fuchs
Hospital de Clínicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 26, 2009
Study Start
February 1, 2008
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
February 25, 2014
Record last verified: 2013-04