Sleep Apnea, Ventricular Arrythmias, Systolic Left Ventricle Dysfunction
Conditions
Keywords
Sleep apnea, CPAP, Ventricular arrhythmias, Defibrillator therapies
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.
Interventions
Nocturnal
Sponsors
Hospital Virgen de la Salud
Hospital Universitario Virgen Macarena
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of appropriate defibrillator therapies | 24 months |
Secondary
| Measure | 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 |
Countries
Spain
Outcome results
None listed