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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  

Heart Failure, Congestive Clinical Trial

Official title:
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 (PRISM)

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01074307
Study type Interventional
Source Merck KGaA
Contact
Status Completed
Phase Phase 4
Start date October 2009
Completion date August 2012
View Details
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