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

Study Design

Observational model cohort
Time perspective prospective
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
cheyne-stokes respiration by adaptive servoventilation

Primary Outcomes

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

Eligibility Criteria

All 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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Ruhr University of Bochum.