Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure (VASA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Medical University of Vienna
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Christoph Schukro, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01979120
First received: November 3, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted

November 3, 2013
November 3, 2013
December 2012
August 2014   (final data collection date for primary outcome measure)
Apnea-Hypopnea-Index [ Time Frame: 1 night ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography) [ Time Frame: 1 night ] [ Designated as safety issue: No ]
Same as current
  • Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • ICD therapies (i.e. shock or anti-tachycardia pacing) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • atrial fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • routine B-type natriuretic peptide [ Time Frame: 1 night ] [ Designated as safety issue: No ]
    only if applicable!
Same as current
 
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure

A prospective observational multi-centre study for the validation of the ApneaScan algorithm (integrated in ICD devices (with or without cardiac resynchronization therapy function) of the "Incepta" series for the screening of sleep disordered breathing in patients with stable symptomatic chronic heart failure, using portable polygraphy monitoring device ("Embletta Gold") as reference for the Apnea-Hypopnea-Index (AHI).

Secondary objectives are the detection of severe sleep disordered breathing in patients with clinically indicated in-laboratory polysomnography, as well as correlations of the AHI detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial fibrillation and ventricular arrhythmia.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series

  • Sleep-disordered Breathing
  • Chronic Heart Failure
Not Provided
only 1 cohort!
All patients already got an ICD implanted which includes an algorithm for screening of sleep-disordered breathing and will be examined by an portable polygraphy monitor in order to compare the Apnea-Hypopnea-Index.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over 18 years
  • Patient´s written informed consent
  • Patients with a cardiac rhythm management device (ICD with or without cardiac resynchronization therapy function) of the "Incepta" series (including the ApneaScan algorithm) already implanted for at least 8 weeks (corresponding to the duration of the leads´ healing process); in order to standardize the enrollment period, inclusion should be effected between the first (the earliest 8 weeks after implantation) and the second routine control of ICD-function (the latest 9 months after implantation)
  • Stable symptomatic chronic heart failure for either ischemic or non-ischemic reason (moderately to severely impaired systolic left ventricular function with NYHA-class II to III) under optimal pharmacological treatment (according to guidelines 2012 of the European Society of Cardiology)

Exclusion Criteria:

  • Unstable heart failure (NYHA-class IV) or asymptomatic chronic heart failure (including patients with very mild exercise induced dyspnea, i.e. NYHA-class I)
  • Patients already treated for sleep apnea syndrome (i.e. continuous positive airway pressure mask) or chronic obstructive pulmonary disease with GOLD-class IV (i.e. long-term oxygen therapy)
  • A limited AHI detection by the ApneaScan algorithm until the planned inclusion (randomly defined by <50% of countable AHI detection-points within the last 2 weeks).
  • Patients with limited mobility due to orthopedic, neurologic or oncologic diseases (because of restricted assessment of exercise induced dyspnea)
  • Patients on dialysis (either acute or chronic)
  • Alcoholism or regular intake of hypnotics
  • Pregnancy and lactation
Both
18 Years and older
No
Contact: Christoph Schukro, MD, PhD +43140400 ext 4614 christoph.schukro@meduniwien.ac.at
Austria,   Germany,   Japan,   Switzerland
 
NCT01979120
ISROTH20033
Yes
Dr. Christoph Schukro, Medical University of Vienna
Dr. Christoph Schukro
Boston Scientific Corporation
Principal Investigator: Christoph Schukro, MD, PhD Medical University of Vienna
Medical University of Vienna
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP