Balloon pulmonary angioplasty combined with riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (PRACTICE study): study protocol for a randomized controlled trial

Table 1 Schedule of visits and observation items for enrolled subjects

Observation items	Visit 1 Screening/baseline	Visit 2 3 months ± 7 days	Visit 3 6 months ± 7 days	Visit 4 12 months ± 7 days
Informed consent	X
Inclusion/exclusion	X
Demographics	X	X	X	X
Medical history	X	X	X	X
vital signs	X	X	X	X
Laboratory tests	X	X	X	X
Blood gas test	X	X	X	X
electrocardiogram	X	X	X	X
6MWD	X	X	X	X
WHO-FC	X	X	X	X
Pulmonary function	X			X
Echocardiography	X		X	X
RHC	X			X
CPET	X		X	X
CMR	X		X	X
QOL (SF-36)	X	X	X	X
Concomitant medication	X	X	X	X
Medication adherence		X	X	X
Adverse events	X	X	X	X

6MWD 6-min walk distance, WHO-FC World Health Organization functional class, RHC right-heart catheterization, CPET cardiopulmonary exercise testing, CMR cardiac magnetic resonance, QOL quality of life

ISSN: 1745-6215