Chronic Heart Failure, Sleep-disordered Breathing
Conditions
Keywords
Sleep-disordered breathing, Chronic heart failure, Implantable cardioverter-defibrillator, Apnea-Hypopnea-Index, Portable Polygraphy Monitoring, Polysomnography
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Dr. Christoph Schukro
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea-Hypopnea-Index | 1 night |
Secondary
| Measure | Time frame |
|---|---|
| Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography) | 1 night |
Other
| Measure | Time frame | Description |
|---|---|---|
| routine B-type natriuretic peptide | 1 night | only if applicable! |
| ICD therapies (i.e. shock or anti-tachycardia pacing) | 2 years | — |
| Hospitalization | 2 years | — |
| Mortality | 2 years | — |
| atrial fibrillation | 2 years | — |
Countries
Austria, Germany, Japan, Switzerland
Contacts
Primary ContactChristoph Schukro, MD, PhD
Outcome results
None listed