Effect of Antihypertensive Agents Over Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diuretics

Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning

Group Type EXPERIMENTAL

Diuretics

Intervention Type DRUG

Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning

Calcium Channel Blockers

Amlodipine 10 mg daily, taking in the morning

Group Type ACTIVE_COMPARATOR

Calcium Channel Blockers

Intervention Type DRUG

Amlodipine 10 mg daily, taking in the morning

Interventions

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Diuretics

Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning

Intervention Type DRUG

Calcium Channel Blockers

Amlodipine 10 mg daily, taking in the morning

Intervention Type DRUG

Other Intervention Names

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Chlorthalidone/Amiloride Amlodipine

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No