A Phase 4 interventional study of Nasal continuous positive airway pressure in Sleep Apnea, Ventricular Arrythmias and Systolic Left Ventricle Dysfunction, sponsored by Hospital Universitario La Paz. Completed at 3 sites in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-02.
Sponsored by Hospital Universitario La Paz · Phase 4, Interventional, and Treatment
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.
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.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 224 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Hospital Universitario La Paz is the lead sponsor of 51 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continuous positive airway pressure
Device: Nasal continuous positive airway pressure
Hygienic-dietetic recommendations
Nocturnal
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
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Paz