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Obstructive Sleep Apnea and Endothelial Function in Patients With Resistant Hypertension

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ClinicalTrials.gov Identifier: NCT01854190
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Antonio Felipe Sanjuliani, Rio de Janeiro State University

Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Secondary Hypertension Device: WatchPAT

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Evaluation of Obstructive Sleep Apnea and Endothelial Function in Resistant Hypertension Patients
Study Start Date : July 2012
Primary Completion Date : January 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

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
Controlled hypertension
Patients with controlled blood pressure by medications. These drugs are the same used in both groups.
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



Primary Outcome Measures :
  1. Prevalence of obstructive sleep apnea [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypertensive patients, from the Hypertension Clinic of UERJ
Criteria

Inclusion Criteria:

  • ages between 18 and 75 years
  • previous hypertension diagnosis

Exclusion Criteria:


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): NCT01854190


Locations
Brazil
Pedro Ernesto University Hospital
Rio de Janeiro, Brazil, 20.551-030
Sponsors and Collaborators
Rio de Janeiro State University
Investigators
Principal Investigator: Antonio F Sanjuliani, MD, ScD Rio de Janeiro State University - Brazil

Responsible Party: Antonio Felipe Sanjuliani, Doctor / Professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01854190     History of Changes
Other Study ID Numbers: CLINEX 02
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: February 2013

Keywords provided by Antonio Felipe Sanjuliani, Rio de Janeiro State University:
Obstructive sleep apnea
Resistent hypertension
Endothelial function
Blood pressure

Additional relevant MeSH terms:
Hypertension
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases