Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
- Conditions
- Sleep Apnea SyndromesHeart Failure, CongestiveAdaptive Servoventilation
- Registration Number
- NCT01657188
- Lead Sponsor
- Ruhr University of Bochum
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
🇩🇪Bad Oeynhausen, Germany
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum🇩🇪Bad Oeynhausen, Germany