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
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