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

Table 1 Study schedule

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 test^a	X		X			X		X	X
NT-pro BNP, hs-CRP	X					X		X
Cardiac biomarkers^b		X				X
Cardiac function (echocardiography)	X								X
Electrocardiogram and HRV		X				X
QOL and symptom questionnaire^c		X						X
Credibility and AES		X				X
Blinding test		X				X
Acupuncture treatment		X	X	X	X	X

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
^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)
^bCardiac biomarkers: atrial natriuretic peptide (ANP), ST2, catecholamine, vasoactive intestinal peptide (VIP), interleukin 6 (IL-6), vascular adhesion protein-1 (VAP-1)
^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