Clinical trial NCT01896661: Effect of Antihypertensive Agents Over Sleep Apnea
Official title: The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Obstructive Sleep Apnea
Keywords: Sleep apnea
Hypertension
Treatment
Diuretics
Chlorthalidone
Amlodipine
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.

Detailed description: This is a randomized, double-blind, clinical trial, comparing the association of Chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). The primary outcomes will be the variation of apneas/hour and blood pressure. The secondary outcomes will be adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein. The follow up will last 8 weeks. The sample size will be of 29 participants per group. The project was approved by the Ethics committee of our institution.

Eligibility criteria: Inclusion Criteria:

* Patients older than 40 years of age
* Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)

Exclusion Criteria:

* Low life expectancy
* Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs
* Pregnancy
* Established cardiovascular disease (myocardial infarction
* Stroke
* Heart failure)
* Use of more than one drug for hypertension
* Secondary hypertension
* Participation in other clinical trial in previous 6 months

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: 8 weeks
measure: Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 8 weeks
measure: Somnolence scale (Epworth) and ventilatory parameters
timeFrame: 8 weeks
measure: C reactive protein
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
name: Flavio D Fuchs, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Fabio T Cichelero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cichelero FT, Martinez D, Fuchs SC, Gus M, Moreira LB, Fuchs FD. The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial. Trials. 2014 Jan 2;15:1. doi: 10.1186/1745-6215-15-1.