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

NCT01074307 | Completed Phase 4 Results

• 1 other identifier: EMD 084000-608
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure, Congestive

Keywords

Systolic heart failure; Bisoprolol; Concor; Echocardiogram

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26

  B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. The percent change of NT-pro BNP was calculated according to the formula: N-terminal pro B-type natriuretic peptide (NT-proBNP) reduction ratio = 100\*(Baseline NT-proBNP - Week 26 NT-proBNP)/Baseline NT-proBNP.

  Baseline and Week 26

Secondary Outcomes (7)

• Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA)

  Baseline and Week 26

• Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26

  Baseline and Week 26

• Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26

  Baseline and Week 26

• Change From Baseline in Echocardiographic Left Ventricular Size at Week 26

  Baseline and Week 26

• Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder

  Baseline up to Week 26

Study Arms (2)

Low Dose Bisoprolol

EXPERIMENTAL

Drug: Low Dose Bisoprolol

High Dose Bisoprolol

EXPERIMENTAL

Drug: High Dose Bisoprolol

Interventions

Low Dose Bisoprolol DRUG

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.

Also known as: Concor

Low Dose Bisoprolol

High Dose Bisoprolol DRUG

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.

Also known as: Concor

High Dose Bisoprolol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Ltd.: collaborator

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: October 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 14, 2014
• Results First Posted: February 14, 2014

Record last verified: 2014-01

Locations

KR (1)