Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing

Conditions
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Heart Failure, Congestive, Sleep Apnea Syndromes, Adaptive Servoventilation

Intervention / Treatment
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* Device: Cheyne-Stokes respiration by adaptive servoventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart failure, sleep-disordered breathing<br>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 | Device: Cheyne-Stokes respiration by adaptive servoventilation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of adaptive servoventilation on heart failure parameters including event free survival | 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. | Time frame for event free survival analysis is up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, congestive, Sleep apnea syndromes, Adaptive servoventilation, Prognosis, Cheyne-Stokes respiration