Sleep Apnea-Hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

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”

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.

Intervention(s) in this Clinical Trial

• Device: Nasal continuous positive airway pressure
  • Nocturnal

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: CPAP
  • Continuous positive airway pressure
• No Intervention: Conventional
  • Hygienic-dietetic recommendations

Primary Measures

• Number of appropriate defibrillator therapies
  • Time Frame: 24 months
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Hospital Universitario La Paz Other

Overall Clinical Trial Officials and Contacts

Francisco Garcia-Rio, PhD Study Director Hospital Universitario La Paz  

Overall Contact: Rafael Peinado, PhD 34917277000 

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00765713

Study ID Number: HULP PI-719

ClinicalTrials.gov Identifier: NCT00765713

Health Authority: Spain: Comité Ético de Investigación Clínica