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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Heart Failure; Sleep-disordered Breathing

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Christoph Schukro, MD, PhD; Phone Number: 4614 +43140400; Email: christoph.schukro@meduniwien.ac.at

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Apnea-Hypopnea-Index	1 night

Secondary Outcome Measures

Outcome Measure	Time Frame
Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)	1 night

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		2 years
Hospitalization		2 years
ICD therapies (i.e. shock or anti-tachycardia pacing)		2 years
atrial fibrillation		2 years
routine B-type natriuretic peptide	only if applicable!	1 night

Collaborators and Investigators

• Sponsor: Dr. Christoph Schukro
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Christoph Schukro, MD, PhD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: November 3, 2013
• First Submitted That Met QC Criteria: November 3, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 3, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Polysomnography; Sleep-disordered breathing; Chronic heart failure; Implantable cardioverter-defibrillator; Apnea-Hypopnea-Index; Portable Polygraphy Monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Heart Failure; Sleep Apnea Syndromes; Respiratory Aspiration
• Other Study ID Numbers: ISROTH20033