Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias (SAHS-ICD)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea; Ventricular Arrythmias; Systolic Left Ventricle Dysfunction
• Intervention / Treatment: Device: Nasal continuous positive airway pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Sevilla, Spain
    • Hospital Universitario Virgen de la Macarena
  • Toledo, Spain
    • Hospital Virgen de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CPAP; Continuous positive airway pressure	Device: Nasal continuous positive airway pressure; Nocturnal
NO_INTERVENTION: Conventional; Hygienic-dietetic recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of appropriate defibrillator therapies	24 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Collaborators: Hospital Universitario Virgen Macarena; Hospital Virgen de la Salud
• Investigators: Study Director: Francisco Garcia-Rio, PhD, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (ESTIMATE): October 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2013
• Last Update Submitted That Met QC Criteria: April 1, 2013
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: CPAP; Ventricular arrhythmias; Sleep apnea; Defibrillator therapies
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Heart Murmurs; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Arrhythmias, Cardiac; Systolic Murmurs
• Other Study ID Numbers: HULP PI-719