A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, open-labeled, multi-centric trial to evaluate the effect of bisoprolol
      (between low dose and high dose) on surrogate markers of heart failure in Korea.
    

Detailed description: 
      Subjects with systolic congestive heart failure (CHF) will be enrolled in this study after
      proper evaluation of 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 [LVEF]). Each subject will be orally administered
      bisoprolol for 6 months starting at 1.25 mg at the Week 0 and titrated up to 10 mg during the
      6 month period if the persistent standing systolic blood pressure (SBP) is greater than (>)
      90 millimeter of mercury (mm Hg) and there is no symptom of hypotension at the current dose
      medication (syncope, loss of consciousness, dizziness when standing up).

      OBJECTIVES

      Primary objective:

      • To evaluate the effect of bisoprolol (between low dose and high dose) on surrogate markers
      of heart failure in Korea

      Secondary objectives:

        -  To evaluate bisoprolol for the effects on clinical improvement of heart failure in
           Korea:

             1. New York Heart Association (NYHA),

             2. 6-minutes walking test

             3. Echocardiogram (left ventricular chamber size and LVEF)

        -  Hospitalization due to heart failure

        -  To evaluate the safety and tolerability of bisoprolol

        -  Global assessment of CHF
    

Intervention name(s): Low Dose Bisoprolol; High Dose Bisoprolol
Intervention type(s): Drug; Drug
Intervention description(s): Bisoprolol tablet (Concor) will be administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose will be further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks.; Bisoprolol tablet (Concor) will be administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose will be subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks.
Other intervention name(s): Concor; Concor
Intervention MeSH terms: Bisoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systolic heart failure; Bisoprolol; Concor; Echocardiogram