Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias (SAHS-ICD)
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|ClinicalTrials.gov Identifier: NCT00765713|
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : April 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Ventricular Arrythmias Systolic Left Ventricle Dysfunction||Device: Nasal continuous positive airway pressure||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||January 2013|
Continuous positive airway pressure
Device: Nasal continuous positive airway pressure
No Intervention: Conventional
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|