Skip to main content

Table 1 Study schedule of assessments

From: Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study

Visit cycle evaluation projects Screening stage Visit 1 Visit 2 Visit 3 Visit 4
Time-Window Day −3–0 Week 4 Week 8 Week 12 Week 16
Inclusion and exclusion criteria     
Informed consent     
Basic condition     
Basic medical history     
Symptoms and signs
Drug combination
Blood routine test, urine routine, liver and kidney function, coagulation function    
Evaluation of cardiopulmonary function (6MWD, WHO-FC, Borg Score, MLHFQ)  
Arterial blood gases    
NT-proBNP, cTNI levels    
Pulmonary function test   
Adverse events  
  1. √, required
  2. Basic medical history contains current medical history (symptoms and signs) and previous history
  3. Evaluation of cardiac and pulmonary function includes a 6-min walk distance (6MWD), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Borg Score, and World Health Organization functional class (WHO-FC)
  4. Safety parameters include routine blood tests and urinalysis, liver and kidney function, and coagulation function