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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Completed

CT.gov ID

NCT01657188

Collaborator

(none)

550

Enrollment

Location

103

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive Sleep Apnea Syndromes Adaptive Servoventilation	Device: Cheyne-Stokes respiration by adaptive servoventilation

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 Design

Study Type:

Observational

Actual Enrollment :

550 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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	Device: Cheyne-Stokes respiration by adaptive servoventilation

Arm

Intervention/Treatment

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

Device: Cheyne-Stokes respiration by adaptive servoventilation

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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