Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias (SAHS-ICD)
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.
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.
|Sleep Apnea Ventricular Arrythmias Systolic Left Ventricle Dysfunction||Device: Nasal continuous positive airway pressure||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Sleep Apnea-hypopnea Syndrome and Ventricular Arrhythmias in Patients With Systolic Ventricular Dysfunction and Implantable Cardioverter-defibrillator. Incidence and Effect of CPAP Treatment|
- Number of appropriate defibrillator therapies [ Time Frame: 24 months ]
- 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 [ Time Frame: 24 moths ]
|Study Start Date:||October 2008|
|Study Completion Date:||January 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Continuous positive airway pressure
Device: Nasal continuous positive airway pressure
No Intervention: Conventional
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765713
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Universitario Virgen de la Macarena|
|Hospital Virgen de la Salud|
|Study Director:||Francisco Garcia-Rio, PhD||Hospital Universitario La Paz|