Enrollment and allocation | Postallocation | Closeout | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit schedule | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | UNS | EOS |
Day/month | Day0 | 1 M | 3 M | 6 M | 9 M | 12 M | 15 M | 18 M | 21 M | 24 M | 27 M | 30 M | 33 M | 36 M | ||
− 14 | ± 3 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | ± 7 | = 2wks | ||
Informed consent | x | |||||||||||||||
Inclusion/exclusion criteria | x | |||||||||||||||
Randomization | x | |||||||||||||||
General data and medical history | x | |||||||||||||||
Medical history of HF | x | |||||||||||||||
Medical history of CV diseases | x | |||||||||||||||
Physical examination | x | x1 | x1 | x1 | x1 | x | x1 | x1 | x1 | x | x1 | x1 | x1 | x | (x) | x |
Heart failure medications | x | x | x | x | x | x | x | x | x | x | x | x | x | x | (x) | x |
Medications of other CVD | x | x | x | x | x | x | x | x | x | x | x | x | x | x | (x) | x |
Other medications | x | x | x | x | x | x | x | x | x | x | x | x | x | x | (x) | x |
TCM Syndrome Diagnosis Questionnaire (SDQHF) | x | x | x | x | x | x | x | |||||||||
Tongue Image Acquisition | x | x | x | x | x | x | x | |||||||||
Echocardiogram | x* | |||||||||||||||
Pregnancy tests | x | x | x | x | (x) | x | ||||||||||
Blood/urine routine test | x | x | x | x | x | (x) | x | |||||||||
Biochemical test | x | x | x | x | x | (x) | x | |||||||||
12-lead ECG | x* | x | x | x | x | (x) | x | |||||||||
Serum NT-proBNP at local laboratory | x | x | x | |||||||||||||
Dispensing IP | x | x | x | x | x | x | x | x | x | x | x | x | x | |||
Returning IP for accountability | x | x | x | x | x | x | x | x | x | x | x | x | x | |||
Endpoint event | x | x | x | x | x | x | x | x | x | x | x | x | x | (x) | x | |
Adverse event | x | x | x | x | x | x | x | x | x | x | x | x | x | (x) | x | |
Serious adverse event | x | x | x | x | x | x | x | x | x | x | x | x | x | (x) | x |