Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

Study Overview
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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.

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.

Official Title
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Sleep Apnea-hypopnea Syndrome and Ventricular Arrhythmias in Patients With Systolic Ventricular Dysfunction and Implantable Cardioverter-defibrillator. Incidence and Effect of CPAP Treatment

Conditions
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Sleep Apnea, Ventricular Arrythmias, Systolic Left Ventricle Dysfunction

Intervention / Treatment
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* Device: Nasal continuous positive airway pressure


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br>Continuous positive airway pressure | Device: Nasal continuous positive airway pressure<br>* Nocturnal<br>|
| No Intervention: Conventional<br>Hygienic-dietetic recommendations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of appropriate defibrillator therapies |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI, incidence of premature ventricular beats and non-sustained ventricular tachycardia. Plasmatic levels of C-reactive protein, homocystein, pro-BNP, sTNFαR-I, IL-1b, IL-2, IL-6, IL-8, IL-8 and 8-isoprostane |  | 24 moths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, CPAP, Ventricular arrhythmias, Defibrillator therapies