Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

Sleep Apnea Clinical Trial

— SAHS-ICD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765713
• Other study ID #: HULP PI-719
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2008
• Last updated: April 1, 2013
• Start date: October 2008
• Est. completion date: January 2013

Study information

• Verified date: September 2008
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Systolic Left Ventricle Dysfunction
• Ventricular Arrythmias

Intervention

Device:
• Nasal continuous positive airway pressure
Nocturnal

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Virgen de la Salud	Toledo

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario La Paz	Hospital Universitario Virgen Macarena, Hospital Virgen de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of appropriate defibrillator therapies		24 months	Yes
Secondary	AHI, incidence of premature ventricular beats and non-sustained ventricular tachycardia. Plasmatic levels of C-reactive protein, homocystein, pro-BNP, sTNFaR-I, IL-1b, IL-2, IL-6, IL-8, IL-8 and 8-isoprostane		24 moths	No