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

Chronic Heart Failure Clinical Trial

— VASA  

Official title:

Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979120
• Other study ID #: ISROTH20033
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2013
• Last updated: November 3, 2013
• Start date: December 2012

Study information

• Verified date: August 2013
• Source: Medical University of Vienna
• Contact: Christoph Schukro, MD, PhD
• Phone: +43140400
• Email: christoph.schukro[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Austrian Agency for Health and Food Safety (AGES)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Respiratory Aspiration
• Sleep-disordered Breathing

Locations

Country	Name	City	State
Austria	Hietzing Hospital	Vienna
Austria	Medical University of Vienna	Vienna
Austria	SMZO	Vienna
Austria	Wilhelminenspital	Vienna
Austria	Wiener Neustadt Hospital	Wiener Neustadt
Germany	Heart and Diabetes centre NRW	Bad Oeynhausen
Germany	Klinikum Coburg	Coburg
Germany	University of Leipzig	Leipzig
Germany	Reinbek Hospital	Reinbek
Japan	Kyushu University	Kyushu
Japan	Tokyo Medical University	Tokyo
Japan	Tottori University	Tottori
Japan	Juntendo University School of Medicine	Urayasu
Switzerland	University of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Christoph Schukro	Boston Scientific Corporation

Countries where clinical trial is conducted

Austria,  Germany,  Japan,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality		2 years	No
Other	Hospitalization		2 years	No
Other	ICD therapies (i.e. shock or anti-tachycardia pacing)		2 years	No
Other	atrial fibrillation		2 years	No
Other	routine B-type natriuretic peptide	only if applicable!	1 night	No
Primary	Apnea-Hypopnea-Index		1 night	No
Secondary	Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)		1 night	No