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Table 1 Inclusion and exclusion criteria

From: Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial

Inclusion criteria

Exclusion criteria

1. Men and women

1. Patients with any of the following symptoms:

2. Age ≥20 years at informed consent acquisition

- Acute sinusitis or otitis media

3. Patients with CHF who are undergoing guideline-directed medical therapy

- Symptoms predisposing vomiting in the mask

4. Patients with CHF capable of using the ASV device at home as outpatients after enrollment

- Incapable of swallowing airway secretions

- Pneumothorax or mediastinal emphysema

5. Patients whose NYHA class at baseline* is greater than or equal to II

- Recent cranial injury or surgery

6. Patients whose LVEF at baseline* is <40%

- Chronic hypoventilation

 

2. Patients at risk of developing any of the following symptoms due to the use of the ASV device

 

- Hypotension or a significant reduction in intravascular volume

 

- Intense nasal bleeding leading to the risk of pulmonary aspiration

 

3. Patients incapable of giving voluntary consent

 

4. Patients with a history of undergoing the treatment of CHF by ASV at home

 

5. Patients who are enrolled in another clinical study or trial

 

6. Patients diagnosed with or suspected of dementia

 

7. Patients whom the attending physician has considered ineligible for this study

  1. *Week 8 before enrollment through day of enrollment. ASV, adaptive servo-ventilation; CHF, chronic heart failure; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association.