Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      At present, there is some clinical data for different functional response to beta-blockers
      associated with beta-adrenergic receptor polymorphisms. But there has been no data reported,
      about the incidence of beta-adrenergic receptor polymorphism and association with
      beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart
      failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the
      purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor
      and the effects of beta-blocker (bisoprolol) in Korean HF subjects.
    

Detailed description: 
      Heart failure impairs the quality of life of an individual and is considered to be the main
      cause of morbidity and mortality. Prognosis of HF subjects depends on severity, age and sex.
      Subjects with HF require lifelong treatment. Pharmacological treatment aims to improve both
      the quality of life and survival of HF subjects.

      OBJECTIVES:

      Primary objective:

        -  To analyze the association between genetic polymorphism of beta-adrenergic receptor and
           the effects of beta-blocker (bisoprolol) in Korean HF subjects

      Secondary objective:

        -  The frequency of polymorphism of beta adrenergic receptor in Korean HF subjects

        -  To evaluate change from baseline in 6-minute walking test, heart rate (HR), blood
           pressure (BP), pro B-type natriuretic peptide (BNP) level at week 26 or End of Treatment
           (EOT)

        -  To compare frequency and duration of hospitalization due to heart failure

      The method involved in this study will be as follows:

        -  Initial evaluation of HF subjects

        -  Blood genomic deoxyribonucleic acid (DNA) isolation and collection

        -  Bisoprolol treatment as add on therapy with standard treatment for HF subject for 6
           months

        -  Genotype of beta adrenergic receptor polymorphism

        -  Follow up evaluation of treated subjects

      Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks
      and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily
      in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable,
      the dose can be increased as 10 mg/day as maximum dose.
    

Intervention name(s): Bisoprolol
Intervention type(s): Drug
Intervention description(s): Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.
Other intervention name(s): Concor
Intervention MeSH terms: Bisoprolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bisoprolol; Chronic Heart failure