ABPM substudy participation
Item
1. Is the subject participating in the ABPM substudy?
boolean
Item
No, select the reason why the subject is not participating in the ABPM substudy
text
Code List
No, select the reason why the subject is not participating in the ABPM substudy
CL Item
Inclusion [I] / exclusion [E] criteria ([1])
CL Item
Site nor participating ([2])
Informed consent
Item
[I06] ABPM 1. Signed written informed consent prior to beginning substudy-related procedures (subject must understand the aims, investigational procedures and possible consequences of the substudy).
boolean
BP criteria
Item
[I07] ABPM 2. Subjects must meet the following BP criteria one day before the parent study Baseline Visit. Subjects without diabetes mellitus or chronic kidney disease: BP <140/90mmHg. Subjects with diabetes mellitus or chronic kidney disease: BP <130/80mmHg.
boolean
changes in antihypertensive medications
Item
[E17] ABPM 1. Any changes in antihypertensive medications within the past 6 weeks.
boolean
Current atrial fibrillation
Item
[E18] ABPM 2. Current atrial fibrillation.
boolean
expected change in antihypertensive medication
Item
[E19] ABPM 3. Subjects who are expected to require a change in antihypertensive medication prior to the Month 3 visit.
boolean
upper arm diameter of >42 cm
Item
[E20] ABPM 4. Subjects with an upper arm diameter of >42 cm.
boolean
night time work
Item
[E21] ABPM 5. Subjects who work at night or whose work schedule includes rotating night time (10:00 PM to 6:00 AM) work.
boolean
Other specification
Item
[OT] Other, specify
text
Item
1. Chronic kidney disease
integer
Code List
1. Chronic kidney disease
CL Item
No medical condition (5)
ABPM device placed on subject
Item
1. Was the ABPM device placed on the subject?
boolean
Date of placement of ABPM device
Item
Yes, date
date
No placement of ABPM device reason
Item
No, provide reason
text
ABPM data capture success
Item
2. Was the ABPM data capture successful?
boolean
ABPM for 24 hours
Item
If not succesful, did the subject wear the ABPM for 24 hours?
boolean
repetition of ABPM
Item
If not succesful, will the ABPM be repeated?
boolean
no repetition of ABPM reason
Item
If no repetition, provide reason
text
ABPM device placed on subject repeat
Item
1. Was the ABPM device placed on the subject?
boolean
Date of placement of ABPM device repeat
Item
Yes, date
date
No placement of ABPM device reason repeat
Item
No, provide reason
text
ABPM data capture success repeat
Item
2. Was the ABPM data capture successful?
boolean
ABPM for 24 hours repeat
Item
If not succesful, did the subject wear the ABPM for 24 hours?
boolean
repetition of ABPM repeat
Item
If not succesful, will the ABPM be repeated?
boolean
no repetition of ABPM reason repeat
Item
If no repetition, provide reason
text
