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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 (PRISM)

This study has been completed.
Sponsor:
Collaborator:
Merck Ltd.
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01074307
First received: February 22, 2010
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
 Drug: Bisoprolol
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Change of surrogate markers of heart failure (NT-proBNP reduction ratio) [ Time Frame: Baseline to Final visit after 6 months ] [ Designated as safety issue: No ]
    NT-proBNP reduction ratio = [100*(baseline NT-proBNP - follow-up NT-proBNP)/baseline NT-proBNP]


Secondary Outcome Measures:
  • Changes of improvement score [ Time Frame: Baseline to Final visit after 6 months ] [ Designated as safety issue: No ]
    NYHA, physician assessment, 6-minutes walking test and echocardiogram

  • Readmission due to aggravation of heart failure, death. [ Time Frame: During the treatment period from Baseline to Final visit after 6 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of bisoprolol [ Time Frame: During the treatment period from Baseline to the Final visit after 6 months ] [ Designated as safety issue: No ]
    Safety and tolerability comprises of observing and recording of adverse events.

  • Occurrence of major clinical event of heart failure [ Time Frame: During the treatment period from Baseline to Final visit ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: October 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bisoprolol
    Bisoprolol will be administered orally 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 SBP is > 90 mm Hg and there is no symptom of hypotension at the current dose medication (syncope, LOC, dizziness at standing up).
    Other Name: Concor
Detailed 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, loss of consciousness (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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with heart failure
  • Subjects aged between 18 to 80 years
  • Subjects with dyspnea with NYHA Class II-IV
  • Subjects with EF ≤ 40% on echocardiography

Exclusion Criteria:

  • Subjects with atrioventricular (AV) block greater than 2nd degree without a functioning pacemaker
  • Subjects with heart rate at rest <60 beats per minute, unless a pacemaker is functioning
  • Subjects with supine systolic blood pressure -100 mmHg at rest
  • Subjects with significant renal impairment defined as a creatinine value >1.5mg/dL
  • Subjects with unrecovered pulmonary edema
  • Subjects with acute myocardial infarction within 3 months prior to randomisation
  • Subjects with percutaneous coronary intervention or coronary bypass surgery performed within 3 months prior to randomisation.
  • Subjects with haemodynamically significant organic valvular disease requiring surgery
  • Subjects with valve replacement within 3 months prior to randomisation
  • Subjects with reversible obstructive lung disease
  • Subjects with previous heart transplant or currently awaiting heart transplant surgery
  • Subjects with other contraindication to beta blocker
  • Subjects with history of malignancy
  • Pregnant or lactating women
  • Subjects with unresolved pleural effusion at discharge
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074307

Locations
Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Merck KGaA
Merck Ltd.
Investigators
Study Director: Medical Responsible Merck Ltd.
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01074307     History of Changes
Other Study ID Numbers: EMD 084000-608
Study First Received: February 22, 2010
Last Updated: February 22, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck KGaA:
Heart Failure, Systolic
Concor
Bisoprolol

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Bisoprolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013