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

This study is currently recruiting participants.
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
  Purpose

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.


Condition
Sleep-disordered Breathing
Chronic Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Apnea-Hypopnea-Index [ Time Frame: 1 night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography) [ Time Frame: 1 night ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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!


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01979120

Contacts
Contact: Christoph Schukro, MD, PhD +43140400 ext 4614 christoph.schukro@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Christoph Schukro, MD, PhD    +43140400 ext 4614    christoph.schukro@meduniwien.ac.at   
Principal Investigator: Christoph Schukro, MD, PhD         
Wilhelminenspital Recruiting
Vienna, Austria
Principal Investigator: Gabriele Jakl, MD         
Hietzing Hospital Recruiting
Vienna, Austria
Principal Investigator: Reinhard Achleitner, MD         
SMZO Recruiting
Vienna, Austria
Principal Investigator: Wolfgang Cozzarini, MD         
Wiener Neustadt Hospital Not yet recruiting
Wiener Neustadt, Austria
Principal Investigator: Alexander Teubl, MD         
Germany
Heart and Diabetes centre NRW Active, not recruiting
Bad Oeynhausen, Germany
Klinikum Coburg Recruiting
Coburg, Germany
Principal Investigator: Johannes Brachmann, MD         
University of Leipzig Active, not recruiting
Leipzig, Germany
Reinbek Hospital Recruiting
Reinbek, Germany
Principal Investigator: Herbert Nägele, MD         
Japan
Kyushu University Not yet recruiting
Kyushu, Japan
Principal Investigator: Shin-Ichi Ando, MD, PhD         
Tokyo Medical University Not yet recruiting
Tokyo, Japan
Principal Investigator: Yoshifumi Takata, MD         
Tottori University Not yet recruiting
Tottori, Japan
Principal Investigator: Masahiko Kato, MD, PhD         
Juntendo University School of Medicine Not yet recruiting
Urayasu, Japan
Principal Investigator: Takatoshi Kasai, MD, PhD         
Switzerland
University of Geneva Recruiting
Geneva, Switzerland
Principal Investigator: Haran Burri, MD         
Sponsors and Collaborators
Dr. Christoph Schukro
Boston Scientific Corporation
Investigators
Principal Investigator: Christoph Schukro, MD, PhD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Dr. Christoph Schukro, Principle Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01979120     History of Changes
Other Study ID Numbers: ISROTH20033
Study First Received: November 3, 2013
Last Updated: November 3, 2013
Health Authority: Austria: Austrian Agency for Health and Food Safety (AGES)

Keywords provided by Medical University of Vienna:
Sleep-disordered breathing
Chronic heart failure
Implantable cardioverter-defibrillator
Apnea-Hypopnea-Index
Portable Polygraphy Monitoring
Polysomnography

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014