NCT01074307

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	Low Dose Bisoprolol	Bisoprolol tablet (Concor) will be administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose will be further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks.
DRUG	High Dose Bisoprolol	Bisoprolol tablet (Concor) will be administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose will be subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks.

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-02-24
• Last updated: 2014-02-14
• Results posted: 2014-02-14

Locations

1 site across 1 country: South Korea