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This is a prospective, open-labeled, multicentric trial to evaluate the effect of bisoprolol (between low-dose and high dose) on surrogate markers of heart failure in Korea.
Subjects with systolic congestive heart failure (CHF) will be enrolled in this study after proper evaluation of N-terminal pro b-type natriuretic peptide (NT-proBNP), global assessment of CHF, 6-minute walking test and improvement score of New York Heart Association (NYHA) and echocardiogram [left ventricular chamber size and ejection fraction (EF)]. Each subject will be orally administered bisoprolol for 6 months starting at 1.25 mg at the Week 0 and titrated upto 10 mg during the 6 month period if the persistent standing systolic blood pressure (SBP) is > 90 mm Hg and there is no symptom of hypotension at the current dose medication (syncope, LOC ?full form, dizziness at standing up.
- To evaluate the effect of bisoprolol (between low-dose and high-dose) on surrogate markers of heart failure in Korea
- To evaluate bisoprolol for the effects on clinical improvement of heart failure in Korea:
1. Global assessment of CHF
2. NYHA, physician assessment, 6 minutes walking test
- To evaluate bisoprolol for the effects on major clinical event of heart failure in Korea
- To evaluate the safety and tolerability of bisoprolol
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Heart Failure, Congestive
Seoul National University Hospital
Korea, Republic of
Published on BioPortfolio: 2014-08-27T03:15:42-0400
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A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
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A semisynthetic digitalis glycoside with the general properties of DIGOXIN but more rapid onset of action. Its cardiotonic action is prolonged by its demethylation to DIGOXIN in the liver. It has been used in the treatment of congestive heart failure (HEART FAILURE).
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Cardiovascular disease (CVD)
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