Clinical trial NCT00765713: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea
Ventricular Arrythmias
Systolic Left Ventricle Dysfunction
Keywords: Sleep apnea
CPAP
Ventricular arrhythmias
Defibrillator therapies
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital Virgen de la Salud
name: Hospital Universitario Virgen Macarena
First posted: 2008-10-03
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of appropriate defibrillator therapies
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 24 moths
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
Study officials:
affiliation: Hospital Universitario La Paz
name: Francisco Garcia-Rio, PhD
role: STUDY_DIRECTOR
References: