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Open Access Highly Accessed Study protocol

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial

Fábio Tremea Cichelero1, Denis Martinez1, Sandra Costa Fuchs1, Miguel Gus2, Leila Beltrami Moreira1 and Flávio Danni Fuchs12*

Author Affiliations

1 Postgraduate Studies Program in Cardiology, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil

2 Division of Cardiology, Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, Brazil

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Trials 2014, 15:1  doi:10.1186/1745-6215-15-1

Published: 2 January 2014

Abstract

Background

Obstructive sleep apnea (OSA) and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. Several drugs are used to control hypertension, but the only consistently effective treatment of OSA is continuous positive airway pressure. The identification of a drug capable of improving OSA and hypertension simultaneously would provide a novel approach in the treatment of both diseases.

Methods/Design

This is a randomized double-blind clinical trial, comparing the use of chlorthalidone with amiloride versus amlodipine as a first drug option in patients older than 40 years of age with stage I hypertension (140 to 159/90 to 99 mmHg) and moderate OSA (15 to 30 apneas/hour of sleep). The primary outcomes are the variation of the number of apneas per hour and blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes are adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein levels. The follow-up will last 8 weeks. There will be 29 participants per group. The project has been approved by the ethics committee of our institution.

Discussion

The role of fluid retention in OSA has been known for several decades. The use of diuretics are well established in treating hypertension but have never been appropriately tested for sleep apnea. As well as testing the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and their treatment.

Trial registration

ClinicalTrials.gov: NCT01896661

Keywords:
Sleep apnea; Hypertension; Treatment; Diuretics; Chlorthalidone; Amlodipine