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Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

NCT00765713 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2013-04-02

No results posted yet for this study

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.

Conditions

  • Sleep Apnea
  • Ventricular Arrythmias
  • Systolic Left Ventricle Dysfunction

Interventions

DEVICE

Nasal continuous positive airway pressure

Nocturnal

Sponsors & Collaborators

  • Hospital Virgen de la Salud

    collaborator OTHER

  • Hospital Universitario Virgen Macarena

    collaborator OTHER

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Francisco Garcia-Rio, PhD · Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00765713 on ClinicalTrials.gov