Table 6 Planned visits and parameters

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