The effect of antihypertensive agents on sleep apnea: protocol for a randomized
controlled trial.
Author(s): Cichelero FT, Martinez D, Fuchs SC, Gus M, Moreira LB, Fuchs FD(1).
Affiliation(s): Author information:
(1)Postgraduate Studies Program in Cardiology, School of Medicine, Universidade
Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. ffuchs@hcpa.ufrgs.br.
Publication date & source: 2014, Trials. , 15:1
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.
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