NCT01657188

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 550 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Cheyne-Stokes respiration by adaptive servoventilation

Timeline

• Start date: 2009-05-01
• Primary completion: 2016-02-01
• Completion: 2017-12-01
• First posted: 2012-08-06
• Last updated: 2019-09-04

Locations

1 site across 1 country: Germany