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Heart Failure, CongestivePhase 4PRISMNCT01074307

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

A Phase 4 study testing Low Dose Bisoprolol and High Dose Bisoprolol in people with Heart Failure, Congestive, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Low Dose Bisoprolol and High Dose Bisoprolol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSouth Korea
Study dates
Oct 2009to Aug 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Subjects with a history of treated or untreated malignant tumor within the past 5 years
  • Pregnant or lactating women
  • Subjects with heart failure due to acute myocarditis
  • Subjects with continuous ventricular tachycardia with history of syncope within 3 months

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Konkuk University Medical Center

    Seoul

Other trials in South Korea

About this study

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)

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.

Read the 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
Being tested
Low Dose Bisoprolol, High Dose Bisoprolol
Keywords
Systolic heart failure, Bisoprolol, Concor, Echocardiogram
Medical subject headings
Heart Failure, Heart Failure, Systolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose BisoprololDrug

    Also called Concor

    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.

  • High Dose BisoprololDrug

    Also called Concor

    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.

Study groups in NCT01074307
Study groupRoleWhat they receive
Low Dose BisoprololExperimentalNot described
Receives: Drug: Low Dose Bisoprolol
High Dose BisoprololExperimentalNot described
Receives: Drug: High Dose Bisoprolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 26

Secondary outcomes (7)

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

    New York Heart Association (NYHA) classification of heart failure: Class I: No limitation: ordinary physical exercise does not cause undue fatigue, dyspnea, or palpitations. Class II: Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations, or dyspnea. Class III: Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms. Class IV: Unable to carry out any physical activity without discomfort: symptoms of heart failure are present even at rest with increased discomfort with any physical activity.

    Measured: Baseline and Week 26

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

    6-minute Walking Test (6-MWT) distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.

    Measured: Baseline and Week 26

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

    LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart.

    Measured: Baseline and Week 26

  4. Change From Baseline in Echocardiographic Left Ventricular Size at Week 26

    Left ventricle size was measured as systolic and diastolic Left Ventricular Internal Dimension (LVID). Diastolic dimension was measured of the left ventricle at the level of the chordae tendineae. The systolic dimension was measured as the smallest dimension between the left septal endocardium and the posterior wall endocardium during systole, whether or not the two walls were exactly apposed.

    Measured: Baseline and Week 26

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

    Measured: Baseline up to Week 26

  6. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.

    Measured: Baseline up to Week 26

  7. Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26

    Global assessment of CHF: The Investigator defined, graded, and recorded the participant's symptoms and signs by using a 6-point CHF scale ranging from 0 (unassessable), 1 (worsened), 2 (no change), 3 (mildly improved), 4 (moderately improved) and 5 (markedly improved).

    Measured: Baseline and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01074307
Sponsor's protocol ID
EMD 084000-608
Acronym
PRISM
Status last verified
Jan 2014
First submitted
22 Feb 2010
Last updated
14 Feb 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low Dose Bisoprolol and High Dose Bisoprolol in people with Heart Failure, Congestive, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26 (time frame: Baseline and Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01074307.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.

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