Overview

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

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck KGaA
Merck KGaA, Darmstadt, Germany
Collaborator:
Merck Ltd.
Treatments:
Adrenergic Agents
Bisoprolol
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