Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea
Brief Summary: The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.


Options:
A: Inclusion Criteria:

* Patients must be at least 22 years old
* Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
* Left ventricular systolic dysfunction (LVEF ≤45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
* NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
* No hospitalisation for heart failure for at least 4 weeks prior to inclusion
* Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE (angiotensin converting Enzyme) inhibitors/ ARB (angiotensin receptor blocker) antagonists the reasons must be documented
* SDB (AHI \> 15/h with ≥ 50% central events and a central AHI ≥ 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
* Patients for whom the use of AutoSet CS2 (TM)/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
* Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

* Significant COPD (chronic obstructive pulmonary disease) with Forced Expiratory Volume within one second (FEV1) \<50% (European Respiratory Society criteria) in the last four weeks before randomisation
* Oxygen saturation at rest during the day ≤ 90% at inclusion
* Current use of Positive Airway Pressure (PAP) - therapy
* Life expectancy \< 1 year for diseases unrelated to chronic HF
* Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
* CRT (cardiac resynchronisation therapy)-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
* Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
* Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
* Acute myocarditis/pericarditis within 6 months prior to randomisation
* Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
* Pregnancy
B: Inclusion Criteria:

* Left ventricular ejection fraction\<50% confirmed by echocardiography
* Apnea hypopnea index(AHI)\>=20 confirmed by overnight polysomnography
* More than 15% of AHI is due to CSA

Exclusion Criteria:

* Changes of cardioactive drug prescriptions within 6 weeks
* Admission due to cardiovascular events within 6 weeks
* Ever used CPAP or ASV for sleep apnea
* Ever used nocturnal oxgen therapy
* Subjects with acute exacerbation of chronic heart failure
* Operation for upper airway within 90 days
* Renal dialysis
* History of stroke with neurological deficit
C: Inclusion Criteria:

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion Criteria:

primary central sleep apnea non-compliance to CPAP therapy
D: Inclusion Criteria:

* Patients 21 years or older
* Patients with prior clinical diagnosis of heart failure (HFrEF or HFpEF), or de novo diagnosis of HFpEF indicated by a local BNP≥300 pg/mL or NT pro-BNP≥1200 pg/mL on admission without systolic blood pressure \>180 mmHg or atrial fibrillation, or diagnosis of HFrEF indicated by documented evidence of prescribed beta-blockers and ACE-inhibitors or ARBs for at least 4 weeks prior to admission
* Hospital admission for acute decompensated HF as determined by:

  * Dyspnea at rest or with minimal exertion

    * AND At least two of the following signs and symptoms:
  * Orthopnea
  * Pulmonary rales beyond basilar
  * Chest congestion on x-ray
  * BNP≥300pg/mL or NT pro-BNP≥1200pg/mL
  * Pulmonary capillary wedge pressure (PCWP) ≥25mmHg during current hospitalization
* Presented to hospital or clinic at least 24 hours prior to consent
* Patient stable enough to stop oxygen use for duration of polygraphy test or have access to dual lumen cannula for polygraphy test
* Sleep disordered breathing (SDB) documented by polygraphy with an AHI≥15 events/hour
* Patient is able to fully understand study information and sign a consent form

Exclusion Criteria:

* Right-sided heart failure without left-sided heart failure
* Sustained systolic blood pressure \<80 mmHg at baseline
* Acute coronary syndrome within 1 months of randomization
* Active myocarditis
* Complex congenital heart disease
* Constrictive pericarditis
* Non-cardiac pulmonary edema
* Clinical evidence of digoxin toxicity
* Need for mechanical hemodynamic support at time of randomization
* Oxygen saturation ≤85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
* COPD exacerbation as the primary reason for hospital admission
* Current use (within 4 weeks of study entry) of any PAP-therapy (eg, fixed, bi-level, or APAP)
* Life expectancy \< 1 year for diseases unrelated to HF
* Transient ischemic attack (TIA) or Stroke within 3 months prior to randomization
* CABG procedure within 3 months prior to randomization, or planned to occur during study period
* CRT implant within 3 months prior to randomization , or planned to occur during study period
* VAD implant planned to occur during study period
* Heart transplant list Status 1a or 1b
* Status post-transplant or LVAD
* Prescribed inotrope therapy anticipated at discharge
* Chronic Dialysis
* Known amyloidosis, hypertrophic obstructive cardiomyopathy, arteriovenous fistulas
* Primary hemodynamically significant uncorrected valvular heart disease (obstructive or regurgitant) with planned intervention within 6 months of randomization
* Pregnant, or planning to become pregnant
* Cannot tolerate ASV treatment during run-in
* Cannot perform 6MWT at baseline
* Occupation as a commercial driver or pilot and plan to be performing these activities during the study period
* Inability to comply with planned study procedures
* Participation in pharmaceutical or treatment-related clinical study within 1 month of study enrollment

Answer: B