Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

Phase 4

Completed

• Conditions: Sleep Apnea; Ventricular Arrythmias; Systolic Left Ventricle Dysfunction
• Interventions: Device: Nasal continuous positive airway pressure

• Registration Number: NCT00765713
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

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

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.

Study Timeline

• Status Verified: 2008-09
• Study Start: 2008-10
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	Nasal continuous positive airway pressure	Continuous positive airway pressure

Primary Outcome Measures

Name	Time	Method
Number of appropriate defibrillator therapies	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Spain