Assessment of clinical effect and treatment quality of immediate-release carvedilol-IR versus SLOW release carvedilol-SR in Heart Failure patients (SLOW-HF): study protocol for a randomized controlled trial

Table 5 Trial process chart

Visit	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5
Status Period	Screening − 2 to 0 week	Baseline 0 months	2 months (± 4 days)	4 months (± 14 days)	6 months (± 14 days)
Inclusion/exclusion criteria	•
Informed consent	•
Demographic data	•
Past medical history^a	•
Randomization		•
Physical examination	•	•	•	•	•
Vital signs	•	•	•	•	•
Height and weight^b	•	•	•	•	•
Blood analysis^c	•	•			•
Urinalysis^d	•	•			•
Pregnancy test^e	•	•			•
Chest x-ray^f	•
12-lead electrocardiograph^g	•				•
Echocardiography^h	•	•			•
Concomitant medication	•	•	•	•	•
Adverse events		•	•	•	•
Patient’s compliance			•	•	•
Questionnaire for quality of life		•			•

^aThe history of diseases, medications, and operations will be recorded
^bCheck weight only after visit 2
^cCBC: WBC with differential count, hemoglobin, hematocrit, platelets; chemistry: albumin, total protein, triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, blood urea nitrogen, serum creatinine, uric acid, total bilirubin, AST, ALT, ALP, NT-proBNP, hs-CRP; electrolytes: Na, K, Ca, Cl, P
^dSpecific gravity, pH, albumin (protein), glucose, blood (occult blood), urobilinogen, ketones
^eWomen of child-bearing age
^f,gExamination at visit 6 can be optionally performed according to the examiner’s decision
^hFollow-up echocardiograph, if available

ISSN: 1745-6215