Adaptive Servoventilation, Heart Failure, Congestive, Sleep Apnea Syndromes
Conditions
Keywords
Heart failure, congestive, Sleep apnea syndromes, Adaptive servoventilation, Prognosis, Cheyne-Stokes respiration
Brief summary
Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival.
Detailed description
The study is intended to investigate therapeutic effects of adaptive servoventilation in patients with sleep-disordered breathing and chronic heart failure. These effects include short-/long-term effects on * symptoms and quality of life * physical and cardiac performance (6min walking test, cardiopulmonary exercise testing) * echocardiographic parameters * arrhythmias * NT-proBNP * Respiratory stability (blood gases, rebreathing test, VE/VCO2-slope in cardiopulmonary exercise testing) * Compliance with ASV therapy * Event free survival (death, heart transplantation, assist device implantation) All of these data are also obtained in patients who basically meet the inclusion criteria but in whom sleep-disordered breathing was excluded by means of cardiorespiratory polygraphy or polysomnography and in patients with sleep-disordered breathing who do not undergo adaptive servoventilation for various reasons.
Interventions
DEVICECheyne-Stokes respiration by adaptive servoventilation
Sponsors
Ruhr University of Bochum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stable heart failure NYHA ≥ II * EF ≤ 45% * without sleep-disordered breathing (apnea-hypopnea-index \<5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy
Exclusion criteria
* Cardiac resynchronization or pacemaker implantation within the last 6 months * Significant COPD with an forced expiratory one-second capacity relative to vital capacity (FEV1/VC)\< 70% (GOLD III) * Respiratory insufficiency requiring long-term oxygen therapy * Daytime hypercapnia at rest (pCO2 \> 45 mmHg) * Current ventilation therapy * Cardiac surgery, PCI, myocardial infarction, unstable angina, TIA or stroke within 12 weeks prior to randomization * Acute myocarditis within 6 months prior to randomization * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influence of adaptive servoventilation on heart failure parameters including event free survival | Time frame for event free survival analysis is up to 8 years | This prospective registry includes heart failure patients with or without accompanied sleep-disordered breathing and investigates its influence on symptoms, cardiac function and performance, quality of life and outcome. |
Countries
Germany
Outcome results
None listed