Obstructive Sleep Apnea and Endothelial Function in Patients With Resistant Hypertension

Completed

• Conditions: Obstructive Sleep Apnea; Secondary Hypertension
• Interventions: Device: WatchPAT

• Registration Number: NCT01854190
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2013-01
• Status Verified: 2013-02
• Study Completion: 2013-05
• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-12
• Last Update Submitted: 2013-05-12
• Study First Posted: 2013-05-15
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ages between 18 and 75 years
• previous hypertension diagnosis

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Resistant hypertension	WatchPAT	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.
Controlled hypertension	WatchPAT	Patients with controlled blood pressure by medications. These drugs are the same used in both groups.

Primary Outcome Measures

Name	Time	Method
Prevalence of obstructive sleep apnea	6 months

Trial Locations

Locations (1)

Pedro Ernesto University Hospital; 🇧🇷 Rio de Janeiro, Brazil