Clinical trial NCT01657188: Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
Official title: Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Sleep Apnea Syndromes
Adaptive Servoventilation
Keywords: Heart failure, congestive
Sleep apnea syndromes
Adaptive servoventilation
Prognosis
Cheyne-Stokes respiration
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of a university hospital

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.

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

Primary outcomes:
measure: Influence of adaptive servoventilation on heart failure parameters including event free survival
timeFrame: Time frame for event free survival analysis is up to 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
Study officials:
affiliation: Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
name: Olaf Oldenburg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: