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Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00929175
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Hypertension Device: active CPAP Device: sham-CPAP Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial
Study Start Date : February 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: active CPAP
auto-PAP with therapeutic pressure
Device: active CPAP
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients

Sham Comparator: sham-CPAP
auto-PAP with pressure less than 1cm H2O
Device: sham-CPAP
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 Measures :
  1. Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring [ Time Frame: 8 weeks after treatment ]

Secondary Outcome Measures :
  1. aldosterone, renin, activated protein C [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929175


Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio grande do sul, Brazil, 90035003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Flavio D Fuchs Hospital de Clínicas de Porto Alegre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00929175     History of Changes
Other Study ID Numbers: 07-020
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: April 2013

Keywords provided by Hospital de Clinicas de Porto Alegre:
Hypertension
Resistant Hypertension
Sleep apnea syndrome
Treatment

Additional relevant MeSH terms:
Hypertension
Sleep Apnea Syndromes
Vascular Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Antihypertensive Agents