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

Ruhr University of Bochum550 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

550

Conditions

Heart Failure, Congestive Sleep Apnea Syndromes Adaptive Servoventilation

Interventions

Cheyne-Stokes respiration by adaptive servoventilationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum

Bad Oeynhausen, Germany

Outcomes

Primary Outcomes

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: Time frame for event free survival analysis is up to 8 years

Data from ClinicalTrials.gov

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