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 (PRISM)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Heart Failure, Congestive

Treatments

Drug: High Dose Bisoprolol

Drug: Low Dose Bisoprolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01074307

EMD 084000-608

Details and patient eligibility

About

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.

Full description

Subjects with systolic congestive heart failure (CHF) will be enrolled in this study after proper evaluation of NT-proBNP, global assessment of CHF, 6-minute walking test and improvement score of New York Heart Association (NYHA) and echocardiogram (left ventricular chamber size and ejection fraction [LVEF]). Each subject will be orally administered bisoprolol for 6 months starting at 1.25 mg at the Week 0 and titrated up to 10 mg during the 6 month period if the persistent standing systolic blood pressure (SBP) is greater than (>) 90 millimeter of mercury (mm Hg) and there is no symptom of hypotension at the current dose medication (syncope, loss of consciousness, dizziness when standing up).

OBJECTIVES

Primary objective:

• To evaluate the effect of bisoprolol (between low dose and high dose) on surrogate markers of heart failure in Korea

Secondary objectives:

To evaluate bisoprolol for the effects on clinical improvement of heart failure in Korea:
1. New York Heart Association (NYHA),
2. 6-minutes walking test
3. Echocardiogram (left ventricular chamber size and LVEF)
Hospitalization due to heart failure
To evaluate the safety and tolerability of bisoprolol
Global assessment of CHF

Enrollment

180 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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