Research into the effect Of SGLT2 inhibition on left ventricular remodelling in patients with heart failure and diabetes mellitus (REFORM) trial rationale and design

Table 1 Overview of all visits and tests scheduled for participants of the REFORM Trial

Visit	Visit 1 screening	Visit 2 baseline/randomisation	Visit 3	Visit 4 tele call	Visit 5	Visit 6 tele call	Visit 7	Visit 8 tele call	Visit 9 final visit	Early discontinuation visit^b
Visit	Up to 4 weeks pre visit 2	Day 0	2 week (±3 days)	4 week (±3 days)	Month 2 (±1 week)	Month 4 (±1 week)	Month 6 (±1 week)	Month 9 (±1 week)	Month 12 (±2 weeks)	As required
Informed consent	X
Check inclusion/exclusion criteria	X
Medical history and family history	X
Clinical examination	X
Demographics	X
Vital signs	X	X	X		X		X		X	X
Safety blood tests and BNP	X^A	X^A	X^B		X^A		X^A		X^A	X ^A
Research bloods		X							X	X
Genetic blood sample (if consented)		X
MRI^a		X							X	X
Bioelectrical composition analysis		X	X		X		X		X	X
Cardiopulmonary exercise testing		X							X	X
6 min walk test		X							X	X
QoL questionnaires		X							X	X
Dispense study medication		X	X		X		X
Adverse event assessment		X	X	X	X	X	X	X	X	X
Record or review concomitant meds	X	X	X	X	X	X	X	X	X	X

Safety blood tests = X^A = U&Es, LFTs, FBC, glucose, HB A1C, BNP: X^B = U&Es, LFTs, FBC, glucose, BNP only
^aScreening MRI to be done only if echo criteria fulfilled. Note MRI can be done (± 2 weeks of scheduled visits 2 and 9 date)
^bEarly discontinuation visit: all tests to be done only where participant agrees
^cUrine pregnancy testing on females of childbearing potential or who do not abstain from sex or use effective contraception

ISSN: 1475-2840