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

Completed

• Conditions: Sleep Apnea Syndromes; Heart Failure, Congestive; Adaptive 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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Primary Completion: 2016-02
• Study Completion: 2017-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

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.

Trial Locations

Locations (1)

Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum; 🇩🇪 Bad Oeynhausen, Germany