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Obstructive Sleep Apnea and Endothelial Function in Patients With Resistant Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Felipe Sanjuliani, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01854190
First received: May 12, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted

May 12, 2013
May 12, 2013
July 2012
January 2013   (final data collection date for primary outcome measure)
Prevalence of obstructive sleep apnea [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Obstructive Sleep Apnea and Endothelial Function in Patients With Resistant Hypertension
Evaluation of Obstructive Sleep Apnea and Endothelial Function in Resistant Hypertension Patients

The purpose of this study is to determine the prevalence of obstructive sleep apnea and associate it with the endothelial function behavior in patients with resistant hypertension. Two groups will be evaluate, one presenting uncontrolled high blood pressure, and other, with controlled blood pressure by drugs.

Introduction: Obstructive sleep apnea (OSA) is considered an independent risk factor for cardiovascular disease. There is evidence that individuals with OSA may have increased inflammatory mediators, changes in the metabolic profile, increased sympathetic activity with consequent elevation of blood pressure (BP) and endothelial dysfunction. Resistant hypertension (RH) is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three hypotensive drugs at full doses, including a diuretic, or the need for >3 medications to control BP. OSA has been reported as the most common secondary cause of high blood pressure maintenance.

Objective: To determine the prevalence of OSA and associate it with the endothelial function behavior in patients with resistant hypertension comparing to those with BP controlled by medication.

Methods: A cross-sectional study involving 40 hypertensive patients (20 with resistant hypertension and 20 with controlled BP), irrespective of race or gender, with ages between 18 and 75 years. BP was measured by oscillometric method on automatic device. Endothelial function was assessed by peripheral arterial tonometry (PAT) by EndoPAT2000® and the OSA diagnosis also through PAT, using the portable device WatchPAT200®. Anthropometric evaluation was performed through measurements of waist, hip and neck circumference, body mass index, waist to height ratio (WHtR), and body composition assessed by bioelectrical impedance. Statistical analyzes were performed by GraphPad Prism software.

Observational [Patient Registry]
Observational Model: Case Control
Time Perspective: Prospective
2 Days
Not Provided
Non-Probability Sample

Hypertensive patients, from the Hypertension Clinic of UERJ

  • Obstructive Sleep Apnea
  • Secondary Hypertension
Device: WatchPAT
BP was measured by oscillometric method on automatic device. Endothelial function was assessed by peripheral arterial tonometry (PAT) by EndoPAT2000® and the OSA diagnosis also through PAT, using the portable device WatchPAT200®. Anthropometric evaluation was performed through measurements of waist, hip and neck circumference, body mass index, waist to height ratio (WHtR), and body composition assessed by bioelectrical impedance.
Other Names:
  • WatchPAT 200 - Itamar Medical
  • EndoPAT 2000 - Itamar Medical
  • Omron 742INT
  • Resistant hypertension

    Patients with uncontrolled blood pressure despite 3 medications, including diuretic.

    Endothelial function assessed by peripheral arterial tonometry (PAT) by EndoPAT and the OSA diagnosis also through PAT, using the portable device WatchPAT.

    Intervention: Device: WatchPAT
  • Controlled hypertension
    Patients with controlled blood pressure by medications. These drugs are the same used in both groups.
    Intervention: Device: WatchPAT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ages between 18 and 75 years
  • previous hypertension diagnosis

Exclusion Criteria:

-

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01854190
CLINEX 02
Yes
Antonio Felipe Sanjuliani, Rio de Janeiro State University
Rio de Janeiro State University
Not Provided
Principal Investigator: Antonio F Sanjuliani, MD, ScD Rio de Janeiro State University - Brazil
Rio de Janeiro State University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP