Skip to main content

Table 1 Inclusion and exclusion criteria

From: 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

Inclusion criteria
 1 Men or women aged 20 years or older
 2 Confirmed left ventricular ejection fraction ≤ 40% by echocardiography within the pre-analytical 6 months
 3 NT-proBNP level ≥ 125 pg/ml or BNP level ≥ 35 pg/ml within the pre-analytical 3 months
 4 Clinically stable patient without evidence of congestion or extracellular fluid retention
 5 Patients providing written informed consent
Exclusion criteria
 1 Systolic blood pressure in a sitting position < 90 mmHg or resting heart rate < 50 beats/min at screening
 2 Patient has a contraindication to beta-blockers
 3 Patient who are expected to take another beta-blocker after randomization
 4 Cardiovascular diseases;
Ischemic heart disease (unstable angina, myocardial infarction) within 1 month
Hypertrophic cardiomyopathy
Cor pulmonale
Hemodynamically significant stenosis of the aorta, aortic valve, or mitral valve
Acute myocardial infarction with complications
 5 Severe cerebrovascular accident (for example, ischemic stroke or cerebral hemorrhage) within the pre-analytical within 6 months
 6 Glottic edema, allergic rhinitis, respiratory diseases with bronchospasm such as asthma and chronic obstructive lung disease
 7 Peripheral vascular disease (for example, Raynaud’s syndrome, intermittent claudication)
 8 Patients who needs vasopressor support due to prominent volume retention/overload
 9 Moderate-to-severe retinopathy (for example, retinal hemorrhage, visual disturbance, retinal microaneurysm within 6 months)
 10 Impaired renal function (serum creatinine ≥ 2.5 mg/dL) or hepatic function (AST or ALT ≥ 3 × ULM)
 11 Patients in a clinical status that can significantly influence absorption, distribution, metabolism, and secretion of drugs for clinical trials:
History of major gastrointestinal surgery, such as gastrectomy or gastric bypass surgery
Inflammatory bowel disease within 12 months
Current gastric ulcer, pancreatic function abnormality including pancreatitis, gastrointestinal/rectal bleeding which requires treatment
Current urologic stenosis or obstruction which requires treatment
 12 Confirmed or suspected drug/alcohol abuse within 6 months
 13 Pregnant or lactating women, suspected pregnant women or lactating women
 14 Chronic inflammatory diseases which require anti-inflammatory treatment
 15 Hypersensitivity to carvedilol
 16 Malignant disease including lymphoma and leukemia within 5 years
 17 Patients who were prescribed other medication for any other clinical trials within the pre-analytical 28 days
 18 Patients who are expected to have prolonged hospital stay due to other medical problems other than chronic heart failure (for example, femoral neck fracture)
 19 Patients who are considered inappropriate by researchers to participate in the clinical trial
  1. ALT alanine transaminase, AST aspartate transaminase, NT-proBNP N-terminal pro B-type natriuretic peptide, ULM upper limit of meta-stability