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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Secondary Hypertension
• Intervention / Treatment: 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
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20.551-030
    • Pedro Ernesto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypertensive patients, from the Hypertension Clinic of UERJ

Description

Inclusion Criteria:

• ages between 18 and 75 years
• previous hypertension diagnosis

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of obstructive sleep apnea	6 months

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Investigators: Principal Investigator: Antonio F Sanjuliani, MD, ScD, Rio de Janeiro State University - Brazil

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 12, 2013
• First Submitted That Met QC Criteria: May 12, 2013
• First Posted (Estimate): May 15, 2013

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Endothelial function; Blood pressure; Resistent hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea
• Other Study ID Numbers: CLINEX 02