Clinical trial NCT01979120: Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
Official title: Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep-disordered Breathing
Chronic Heart Failure
Keywords: Sleep-disordered breathing
Chronic heart failure
Implantable cardioverter-defibrillator
Apnea-Hypopnea-Index
Portable Polygraphy Monitoring
Polysomnography
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2013-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Apnea-Hypopnea-Index
timeFrame: 1 night
Secondary outcomes:
measure: Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)
timeFrame: 1 night
Other outcomes:
measure: Mortality
timeFrame: 2 years
measure: Hospitalization
timeFrame: 2 years
measure: ICD therapies (i.e. shock or anti-tachycardia pacing)
timeFrame: 2 years
measure: atrial fibrillation
timeFrame: 2 years
measure: routine B-type natriuretic peptide
timeFrame: 1 night
Locations:
city: Vienna
country: Austria
facility: Hietzing Hospital
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: SMZO
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Wiener Neustadt
country: Austria
facility: Wiener Neustadt Hospital
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes centre NRW
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Leipzig
country: Germany
facility: University of Leipzig
city: Reinbek
country: Germany
facility: Reinbek Hospital
city: Kyushu
country: Japan
facility: Kyushu University
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Tottori
country: Japan
facility: Tottori University
city: Urayasu
country: Japan
facility: Juntendo University School of Medicine
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: Medical University of Vienna
name: Christoph Schukro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: