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A Prospective, Open-labeled Trial in Patients With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea

2014-08-27 03:15:42 | BioPortfolio

Summary

This is a prospective, open-labeled, multicentric trial to evaluate the effect of bisoprolol (between low-dose and high dose) on surrogate markers of heart failure in Korea.

Description

Subjects with systolic congestive heart failure (CHF) will be enrolled in this study after proper evaluation of N-terminal pro b-type natriuretic peptide (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 (EF)]. Each subject will be orally administered bisoprolol for 6 months starting at 1.25 mg at the Week 0 and titrated upto 10 mg during the 6 month period if the persistent standing systolic blood pressure (SBP) is > 90 mm Hg and there is no symptom of hypotension at the current dose medication (syncope, LOC ?full form, dizziness at 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. Global assessment of CHF

2. NYHA, physician assessment, 6 minutes walking test

3. Echocardiogram

- To evaluate bisoprolol for the effects on major clinical event of heart failure in Korea

- To evaluate the safety and tolerability of bisoprolol

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Heart Failure, Congestive

Intervention

Bisoprolol

Location

Seoul National University Hospital
Seoul
Korea, Republic of

Status

Recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

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