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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Ltd.
• Treatments: Bisoprolol

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