Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
This trial is active, not recruiting.
|Conditions||heart failure, congestive, sleep apnea syndromes, adaptive servoventilation|
|Treatment||cheyne-stokes respiration by adaptive servoventilation|
|Sponsor||Ruhr University of Bochum|
|Start date||May 2009|
|End date||December 2021|
|Trial size||1500 participants|
|Trial identifier||NCT01657188, HDZNRW_KA_001_OO|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Patients with stable heart failure NYHA ≥ II, EF ≤ 45% with or without central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation
Influence of adaptive servoventilation on heart failure parameters including event free survival
time frame: Time frame for event free survival analysis is up to 8 years
Male or female participants at least 18 years old.
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
|Official title||Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing|
|Principal investigator||Olaf Oldenburg, M.D.|
|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.|
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