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
Intervention: Low Dose Bisoprolol; High Dose Bisoprolol
Intervention description: 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.
Intervention MeSH terms: Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Systolic heart failure; Bisoprolol; Concor; Echocardiogram

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with heart failure and at the age of 18 (inclusive) to 80 (exclusive)

          -  Subjects with NYHA Class II-IV with dyspnea

          -  Subjects with left ventricular ejection fraction (LVEF) of 40 percent or below on the
             echocardiogram

          -  Eligible subjects who meet the criteria, are capable of participating in the study,
             and provide written informed consent to study participation after receiving a clear
             explanation about the study objective and nature

        Exclusion Criteria:

          -  A subject who cannot understand or does not agree to the study contents

          -  Subjects with conduction defect of 2nd degree or above atrioventricular block

          -  Subjects with heart rate less than (<) 60 beats at rest

          -  Subjects with systolic blood pressure < 100 mm Hg at rest

          -  Subjects with renal failure (serum creatinine > 2.0 milligram per deciliter [mg/dL])

          -  Subjects with unrecovered pulmonary edema

          -  Subjects with history of myocardial infarction or stroke within 3 months

          -  Subjects with history of coronary intervention or coronary bypass within 6 months

          -  Subjects with heart failure due to mitral valve without valve replacement or aortic
             valvular disease (excluding moderate or less severe mitral insufficiency secondary to
             left ventricular expansion)

          -  Subjects with history of valve replacement within the past 6 months

          -  Subjects with history or scheduled heart transplantation

          -  Subjects with reversible obstructive pulmonary disease

          -  Subjects with other cases where beta blockers are contraindicated

          -  Any surgical or internal disease that may put the subject at a higher risk due to
             study participation or may interfere with the subjects compliance to study
             requirements or completion of the study, based on the judgment of the Investigator

          -  A subject with history of non-compliance to drug prescriptions or who is not willing
             to comply with the protocol

          -  Subjects with a history of treated or untreated malignant tumor within the past 5
             years

          -  Pregnant or lactating women

          -  Subjects with heart failure due to acute myocarditis

          -  Subjects with continuous ventricular tachycardia with history of syncope within 3
             months