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Table 1 Study conduction flowchart overview of all visit and tests scheduled for participants of the EMPA-HEART trial

From: Impact of empagliflozin on subclinical left ventricular dysfunctions and on the mechanisms involved in myocardial disease progression in type 2 diabetes: rationale and design of the EMPA-HEART trial

Visits

Screening

Run-in

Baseline

Entry

1 Month

6 Months

Study end

Time (week)

− 5

− 3

− 1

0

4

24

26

Medical history

 

X

    

X

Physical examination

 

X

 

X

X

 

X

ECG

 

X

    

X

Preliminary I/E criteria

X

      

Definitive I/E criteria

   

X

   

Informed consent

X

      

Randomization

   

X

   

Drug prescription

   

X

   

Biomarkers

 

X

    

X

Body water assessment

X

     

X

Safety sample

 

X

    

X

Drug compliance

      

X

Adverse effect

    

X

 

X

Cardiac autonomic tests

 

X

    

X

Exercise test

  

X

  

X

 

Echocardiography

  

X

 

X

X

 
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Cardiovascular Diabetology

ISSN: 1475-2840