Status:
COMPLETED
Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias
Lead Sponsor:
Hospital Universitario La Paz
Collaborating Sponsors:
Hospital Virgen de la Salud
Hospital Universitario Virgen Macarena
Conditions:
Sleep Apnea
Ventricular Arrythmias
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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-hyp...
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 gene...
Eligibility Criteria
Inclusion
- Previous diagnostic of ischaemic heart disease of dilated myocardiopathy
- Ejection fraction of left ventricle \< 40%
- Patients with implantable cardioverter-defibrillator
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00765713
Start Date
October 1 2008
End Date
January 1 2013
Last Update
April 2 2013
Active Locations (3)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
2
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, Spain
3
Hospital Virgen de la Salud
Toledo, Toledo, Spain