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Table 1 Study schedule

From: Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial

Study period Screening visit Acupuncture treatment period Follow-up period
Visit Screening D1 D2 D3 D4 D5 V1 V2 V3
Informed consent X         
Demographics and history collection X         
Inclusion and exclusion criteria X         
Randomization   X        
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   X    X   X X
NT-pro BNP, hs-CRP X      X   X  
Cardiac biomarkersb   X     X    
Cardiac function (echocardiography) X         X
Electrocardiogram and HRV   X     X    
QOL and symptom questionnairec   X       X  
Credibility and AES   X     X    
Blinding test   X     X    
Acupuncture treatment   X X X X X    
  1. Abbreviations: AES acupuncture expectancy scale, D5 date of discharge, hs-CRP high-sensitivity C-reactive protein, HRV heart rate variability, NT-pro BNP N-terminal pro b-type natriuretic peptide, NYHA New York Heart Association, QOL quality of life, V1 7 days post-discharge ±5 days, V2 28 days post-discharge ±7 days, V3 180-days post discharge ±14 days
  2. aRoutine blood test: complete blood cell count and different counts (CBC, DC), blood urea nitrogen (BUN), creatinine, electrolyte (Na, K, Cl), total bilirubin, glucose, total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT)
  3. bCardiac biomarkers: atrial natriuretic peptide (ANP), ST2, catecholamine, vasoactive intestinal peptide (VIP), interleukin 6 (IL-6), vascular adhesion protein-1 (VAP-1)
  4. cQOL and symptom questionnaire: EuroQol five dimensions questionnaire (EQ-5D), Minnesota Living with Heart Failure Questionnaire (MLHFQ), pattern identification questionnaire according traditional East Asian medicine theory