Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

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

PHASE4

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-01-31

Brief Summary

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Hypothesis:

The CPAP treatment diminishes the effect of ventricular arrhythmias in patients with ischemic heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep apnea-hypopnea syndrome (SAHS)Objectives: To analyze the incidence of ventricular arrhythmias (premature ventricular beat, non-sustained ventricular tachycardia and sustained ventricular tachycardia) and appropriate defibrillator therapies in patients with ischemic heart disease or dilated myocardiopathy, moderate-severe left ventricular dysfunction,with an implantable cardioverter-defibrillator (ICD) and sleep apnea. To study the effect of CPAP on the cardiac arrhythmias and on the number of appropriate defibrillator therapies.

Design:

Parallel, randomized and single-blinded multicentric study to compare CPAP vs. hygienic-dietetic recommendations.

Patients with SAHS (AHI≥15) and systolic left ventricle dysfunction patients with an ICD.

Duration: 24 months.

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Detailed Description

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Secondary objectives:

To compare the prevalence of SAHS in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with ICD with that of the general population. To study the incidence of supraventricular arrhythmias (atrial fibrillation, atrial flutter or supraventricular tachycardia) and inappropriate defibrillator therapies in these patients. To value the effect of the treatment with CPAP on the above mentioned arrhythmias. To relate the effect of ventricular and supraventricular arrhythmias with sleep parameters, cardiovascular biomarkers, inflammation and oxidative stress. To evaluate the long-term effect of the CPAP on systemic biomarkers in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction. To evaluate the long-term effect of CPAP on the quality of life in these patients.

Sample size:

224 patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with ICD will be included to randomize 19 SAHS subjects for arm.

Conditions

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Sleep Apnea Ventricular Arrythmias Systolic Left Ventricle Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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CPAP

Continuous positive airway pressure

Group Type EXPERIMENTAL

Nasal continuous positive airway pressure

Intervention Type DEVICE

Nocturnal

Conventional

Hygienic-dietetic recommendations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nasal continuous positive airway pressure

Nocturnal

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Previous diagnostic of ischaemic heart disease of dilated myocardiopathy
* Ejection fraction of left ventricle \< 40%
* Patients with implantable cardioverter-defibrillator

Exclusion Criteria

* Diurnal hypersomnolence with EES \> 16
* Morbid obesity (BMI \> 35 Kg/m2).
* Moderate-severe chronic obstructive pulmonary disease (FEV1/FVC \< 70 % and FEV1 \< 80 % of reference).
* Known thyroid disease.
* Previous treatment with CPAP.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes