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

Table 2 Schedule for observation, testing, and assessment

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		×	×

¹Without the ASV device, a device for sleep study (type 1, 2, or 3) is used. ²Without the ASV device, a device for sleep study (types 1, 2, 3, or 4) is used. ASV, adaptive servo-ventilation; NYHA, New York Heart Association.

ISSN: 1745-6215