Table 2.
Follow-up schedule
Eligibility test | 0 week | 12 weeks | 24 weeks | |
---|---|---|---|---|
Patient information/obtaining consent | a | |||
Patient background | a | |||
Interview/physical examination | a | a | a | a |
Confirmation of drug compliance | a | a | ||
Confirmation of study procedure compliance | a | a | a | |
Confirmation of concomitant drug use | a | a | a | a |
Height | a | |||
Body weight/body temperature | a | a | b | a |
Blood pressure/pulse rate | a | b | a | |
Blood tests | a | a | b | a |
Blood tests (specific) | a | b | a | |
12-lead ECG | a | a | ||
Holter monitoring | a | a | ||
Echocardiography | a | a | a | |
123I-MIBG myocardial scintigraphy | b | b | ||
Safety assessment | a | a | a | a |
Evaluation of ICD | a | a |
aPrimary or secondary outcome measure
bOptional