A prospective, randomized, placebo-controlled, double-blind, multicenter study of the effects of irbesartan on aortic dilatation in Marfan syndrome (AIMS trial): study protocol

Table 1 Study-related investigations and follow-up

Procedure	Visit 0	Visit 1	Visit 2	Visit *	Telephone call	Visit 3	Telephone call	Visit 4	Telephone call	Visit 5	Telephone call	Visit 6	Telephone call	Visit 7
	Month 1, run-in phase, 75 mg open-label	Month 2, baseline, 150 mg active/placebo for 1 month	Month 3, uptitration to 300 mg active/placebo or maintenance at 150 mg active/placebo	Month 4, titration visit (if necessary)	Month 6, 9	Year 1 (month 12)	Month 15, 18, 21	Year 2 (month 24)	Month 27, 30, 33	Year 3, (month 36)	Month 39, 42, 45	Year 4 (month 48)	Month 51, 54, 57	Year 5 (month 60)
Screening	√
Compliance check			√	√		√	√	√	√	√	√	√	√	√
Clinical evaluation	√	√	√	√		√		√		√		√		√
Informed consent	√	√
Randomization		√
Blood pressure	√	√	√	√		√		√		√		√		√
Echocardiogram	√					√		√		√		√		√
ECG	√	√				√		√		√		√		√
Medications	√	√	√	√		√		√		√		√		√
Liver function		√	√	√		√		√		√		√		√
Full blood count		√	√	√		√		√		√		√		√
Urea and electrolytes		√	√	√		√		√		√		√		√
Renal function	√	√	√	√		√		√		√		√		√
Study drug given	√	√	√	√		√		√		√		√
Mutation analysis (if necessary)	√
Blood sample (TGF-β and other biomarkers)	√					√

Visit * only required if patient does not tolerate 300 mg dose. Patient will be downtitrated to 150 mg OD. ECG, electrocardiography; OD, once daily; TGF-β, transforming growth factor beta.

ISSN: 1745-6215