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Table 3 Planned visits and parameters

From: Study protocol: Traditional Chinese Medicine (TCM) syndrome differentiation for heart failure patients and its implication for long-term therapeutic outcomes of the Qiliqiangxin capsules

 

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

  1. X1 Simplified physical examination
  2. x* Cardiac ultrasound and 12-lead ECG within the first 6 months of enrollment
  3. UNS (unplanned visit): (x) The marked item is optional and performed according to the judgment of researchers
  4. EOS (final visit): Make arrangement according to the study end time (if there is a visit within one month before the end of study, it is regarded as a final visit, but needs to be supplemented with the items required completely)
  5. 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)