Does dapagliflozin regress left ventricular hypertrophy in patients with type 2 diabetes? A prospective, double-blind, randomised, placebo-controlled study

Table 1 Overview of all the study visits in the DAPALVH trial

Visit	1 Screening	2 Baseline^a	3 follow-up^a	4 Follow-up^a	5 Follow-up^a	6 Last visit^a
Timeline - weeks	0 to − 4	0 Within 4 weeks of screening visit	4^b [+/− 1 week]	17 [+/− 4 weeks]	34 [+/− 4 weeks]	52 [+/− 4 weeks]
Informed Consent	X
Medical History	X
Demographics	X
Concomitant Medications	X	X	X	X	X	X
Physical Examination	X
Height & weight	X
BP & P	X	X	X	X	X	X
Temperature	X
ECG	X
Echo^c	X					X
Safety Bloods^d	X	X	X	X	X	X
Inclusion/Exclusion	X
Pregnancy Testing if applicable^e	X	X	X	X	X	X
Research Blood Sample ^f		X	X	X	X	X
Genetic blood sample		X
24 h BP		X				X
Cardiac & abdominal MRI^g		X				X
Waist & hip measurement		X	X	X	X	X
Adjustment of diabetes medication		X	X	X	X
Adjustment of anti-hypertensive medication		X	X	X	X
Record Adverse Events		X	X	X	X	X
Randomisation		X
Dispense Trial Drugs		X^h	X	X	X
Return trial drugs			X	X	X	X

^aParticipants will be fasted for these visits
^bAt least 3 weeks after commencing study medication
^cIf a participant has had a clinical echo done within the previous 6 months the results from this will be used for assessing eligibility, otherwise an echo will be performed at the screening visit
^dU&E, FBC, LFT, cholesterol, HDL-cholesterol
^eSee section 7.2
^fHbA1c, FIRI, BNP, glucose, uric acid. A sample to be held for future research will be taken at the last visit
^gThe MRI scan may be performed ± 3 weeks from the baseline visit and may therefore require a separate visit
^hIf the participant as not yet had their MRI scan they will be asked not to start their study medication until they have had their scan. Their Visit 3 will be delayed until the patient has had at least 3 weeks of study medication

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