Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.

NCT ID: NCT01104558

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-07-31

Brief 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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bisoprolol

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 Type: DRUG

Other Intervention Names

Concor

Eligibility Criteria

Inclusion Criteria

• >18 years of age and <80 years of age
• Chronic heart failure subjects with stable clinical condition
• New York Heart Association (NYHA) functional classification II-III
• Left ventricular ejection fraction (LVEF) ≤45%

Exclusion Criteria

• NYHA functional classification IV
• Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft, Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months
• Hypersensitivity to bisoprolol or any of the Concor excipients
• Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary insufficiency
• Systolic Blood Pressure <90 millimeters of mercury (mmHg) at screening
• Resting Heart Rate <55 beats per minute (bpm) confirmed by electrocardiogram (ECG) at screening
• Subjects who are taking concomitant drug which can have drug-drug interaction (DDI) with bisoprolol
• Woman of childbearing age without effective contraception measures, or who are pregnant or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Ltd.

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Ltd.

Locations

The Catholic University of Korea Seoul St. Mary's Hospital, 505, Banpodong, SeoChoGu

Seoul, , South Korea

Countries

South Korea

Other Identifiers

EMD084000-500

Identifier Type: -

Identifier Source: org_study_id