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

Table 1 Study schedule of assessments

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	√
Complication	√	√	√	√	√
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)	√	√		√	√
Electrocardiogram	√				√
Imaging	√
Arterial blood gases	√				√
NT-proBNP, cTNI levels	√				√
Echocardiography	√		√		√
Pulmonary function test	√		√		√
Adverse events		√	√	√	√

√, required
Basic medical history contains current medical history (symptoms and signs) and previous history
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)
Safety parameters include routine blood tests and urinalysis, liver and kidney function, and coagulation function

ISSN: 1745-6215