Study period | Screening visit | Acupuncture treatment period | Follow-up period | ||||||
---|---|---|---|---|---|---|---|---|---|
Visit | Screening | D1 | D2 | D3 | D4 | D5 | V1 | V2 | V3 |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â |
Demographics and history collection | X | Â | Â | Â | Â | Â | Â | Â | Â |
Inclusion and exclusion criteria | X | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization | Â | X | Â | Â | Â | Â | Â | Â | Â |
Physical examination and vital signs check | X | X | X | X | X | X | X | X | X |
Body weight | X | X | X | X | X | X | X | X | X |
Symptoms check (NYHA Functional Class) | X | X | X | X | X | X | X | X | X |
Adverse events | X | X | X | X | X | X | X | X | X |
Concomitant medication check | X | X | X | X | X | X | X | X | X |
Routine blood testa | X | Â | X | Â | Â | X | Â | X | X |
NT-pro BNP, hs-CRP | X | Â | Â | Â | Â | X | Â | X | Â |
Cardiac biomarkersb | Â | X | Â | Â | Â | X | Â | Â | Â |
Cardiac function (echocardiography) | X | Â | Â | Â | Â | Â | Â | Â | X |
Electrocardiogram and HRV | Â | X | Â | Â | Â | X | Â | Â | Â |
QOL and symptom questionnairec | Â | X | Â | Â | Â | Â | Â | X | Â |
Credibility and AES | Â | X | Â | Â | Â | X | Â | Â | Â |
Blinding test | Â | X | Â | Â | Â | X | Â | Â | Â |
Acupuncture treatment | Â | X | X | X | X | X | Â | Â | Â |