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

NCT ID: NCT01657188

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Heart Failure, Congestive; Sleep Apnea Syndromes; Adaptive Servoventilation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart failure, sleep-disordered breathing

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

Intervention Type: DEVICE

Interventions

Cheyne-Stokes respiration by adaptive servoventilation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Olaf Oldenburg

Senior cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olaf Oldenburg, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bad Oeynhausen, , Germany

Countries

Germany

Other Identifiers

HDZNRW_KA_001_OO

Identifier Type: -

Identifier Source: org_study_id