Acquisition means | Examination items | Timing (allowable range) | ||
---|---|---|---|---|
 |  | Baseline: week 8 before enrollment through day of enrollment | Week 12 (±4 weeks) | Day of study discontinuation or day of study completion at week 24 (±4 weeks) |
Case report form | Patient background | × |  |  |
Combined therapy | × | × | × | |
Symptoms (NYHA class and self-assessment of daytime sleepiness) | × | × | × | |
Quality of life and activities of daily living | × | × | × | |
Vital signs | × | × | × | |
Physical examination | × | × | × | |
Echocardiography | × | × | × | |
Chest X-ray | × | × | × | |
Brain natriuretic peptide | × | × | × | |
Hematology | × | × | × | |
Sleep study | ×1 | × | Wherever possible2 | |
Cardiac event |  | × | × | |
Usage of the ventilator in the ASV group | × | × | × | |
Adverse events |  | × | × | |
Electronic means | Echocardiogram | × | × | × |
Air flow in the sleep study | ×1 |  | Wherever possible2 | |
Usage of the ventilator in the ASV group |  | × | × |