Clinical trial NCT01854190: Obstructive Sleep Apnea and Endothelial Function in Patients With Resistant Hypertension
Official title: Evaluation of Obstructive Sleep Apnea and Endothelial Function in Resistant Hypertension Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Secondary Hypertension
Keywords: Obstructive sleep apnea
Resistent hypertension
Endothelial function
Blood pressure
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients, from the Hypertension Clinic of UERJ

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.

Eligibility criteria: Inclusion Criteria:

* ages between 18 and 75 years
* previous hypertension diagnosis

Exclusion Criteria:

-

Primary outcomes:
measure: Prevalence of obstructive sleep apnea
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Pedro Ernesto University Hospital
Study officials:
affiliation: Rio de Janeiro State University - Brazil
name: Antonio F Sanjuliani, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References: