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
  Purpose

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 Intervention
Obstructive Sleep Apnea
Secondary Hypertension
Device: WatchPAT

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • Prevalence of obstructive sleep apnea [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 12, 2013
Last Updated: May 12, 2013
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on July 26, 2014