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Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea

Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: active CPAP (Device); sham-CPAP (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital de Clinicas de Porto Alegre

Official(s) and/or principal investigator(s):
Flavio D Fuchs, Principal Investigator, Affiliation: Hospital de ClĂ­nicas de Porto Alegre

Summary

Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.

Clinical Details

Official title: Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring

Secondary outcome: aldosterone, renin, activated protein C

Detailed description: This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP

Eligibility

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of resistant hypertension

- Apnea/hypopnea index > 15

Exclusion Criteria:

- Cardiac surgery on last 3 months

- Serious arrhythmias

- Insulin dependent diabetes

- Debilitating neurological disease

- severe COPD

Locations and Contacts

Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio grande do sul 90035003, Brazil
Additional Information

Starting date: February 2008
Last updated: February 24, 2014

Page last updated: August 20, 2015

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