Table 6.
Planned visits and parameters
| Visit Schedule | Enrollment & Allocation | Post allocation | Closeout | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |
x1Simplified physical examination
x* Cardiac ultrasound and 12-lead ECG within the first 6 months of enrollment
UNS (unplanned visit): (x) The marked item is optional and performed according to the judgment of researchers
EOS (final visit): Make arrangement according to the study end time (if there is a visit within one month before the end of the study, it is regarded as a final visit, but needs to be supplemented with the items required completely)
Pregnancy test is only applicable to women of childbearing age (if the urine pregnancy test is positive, it must be confirmed by serum pregnancy test)