Obstructive Sleep Apnea and Endothelial Function in Patients With Resistant Hypertension

NCT01854190 | Completed DMC

• 1 other identifier: CLINEX 02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Secondary Hypertension

Keywords

Obstructive sleep apnea; Resistent hypertension; Endothelial function; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Prevalence of obstructive sleep apnea

  6 months

Study Arms (2)

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

Controlled hypertension

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

Device: WatchPAT

Interventions

WatchPAT DEVICE

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.

Also known as: WatchPAT 200 - Itamar Medical, EndoPAT 2000 - Itamar Medical, Omron 742INT

Controlled hypertension; Resistant hypertension

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertensive patients, from the Hypertension Clinic of UERJ

You may qualify if:

• ages between 18 and 75 years
• previous hypertension diagnosis

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

Pedro Ernesto University Hospital

Rio de Janeiro, Rio de Janeiro, 20.551-030, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Antonio F Sanjuliani, MD, ScD

  Rio de Janeiro State University - Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor / Professor

Study Record Dates

• First Submitted: May 12, 2013
• First Posted: May 15, 2013
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-02

Locations

BR (1)