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Completed

NCT Number: NCT00765713

Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Systolic Left Ventricle Dysfunction Ventricular Arrythmias

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasal Continuous Positive Airway Pressure

Device

Nocturnal

Primary outcomes

  1. Number of appropriate defibrillator therapies

    Time frame: 24 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Collaborators

  • Hospital Universitario Virgen Macarena
  • Hospital Virgen de la Salud

Registry information

Official study title

Sleep Apnea-hypopnea Syndrome and Ventricular Arrhythmias in Patients With Systolic Ventricular Dysfunction and Implantable Cardioverter-defibrillator. Incidence and Effect of CPAP Treatment

Acronym: SAHS-ICD

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Oct 3, 2008
Registry last updated
Apr 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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