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

This study has been completed.
Sponsor:
Collaborators:
Hospital Virgen de la Salud
Hospital Virgen de la Macarena
Information provided by:
Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT00765713
First received: October 2, 2008
Last updated: April 1, 2013
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Apnea
Ventricular Arrythmias
Systolic Left Ventricle Dysfunction
 Device: Nasal continuous positive airway pressure
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario La Paz:

Primary Outcome Measures:
  • Number of appropriate defibrillator therapies [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: October 2008
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP
Continuous positive airway pressure
 Device: Nasal continuous positive airway pressure
Nocturnal
No Intervention: Conventional
Hygienic-dietetic recommendations

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765713

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Macarena
Sevilla, Spain
Hospital Virgen de la Salud
Toledo, Spain
Sponsors and Collaborators
Hospital Universitario La Paz
Hospital Virgen de la Salud
Hospital Virgen de la Macarena
Investigators
Study Director: Francisco Garcia-Rio, PhD Hospital Universitario La Paz
  More Information

No publications provided

Responsible Party: Rafael Peinado Peinado, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT00765713     History of Changes
Other Study ID Numbers: HULP PI-719
Study First Received: October 2, 2008
Last Updated: April 1, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario La Paz:
Sleep apnea
CPAP
Ventricular arrhythmias
Defibrillator therapies

Additional relevant MeSH terms:
Apnea
Arrhythmias, Cardiac
Sleep Apnea Syndromes
Ventricular Dysfunction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013