Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Brief Summary: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.


Options:
A: 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
B: Inclusion Criteria:

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion Criteria:

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

* Diagnosis of complex sleep apnea syndrome (CompSAS)
* Naive to PAP therapy
* Requires CPAP ≤15 cm H2O

Exclusion Criteria:

* Requires supplemental oxygen or with a baseline SaO2 \<90%
* Requires CPAP \> 15 cm H2O
* Primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure
* Any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status

Answer: C