Trial · 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
NCT01074307, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2014-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01074307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01074307
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01074307
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 180 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Heart Failure, Congestive
- Interventions
- Low Dose Bisoprolol, High Dose Bisoprolol
- First posted
- 2010-02-24
- Last updated
- 2014-02-14
- Results first posted
- 2014-02-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26 | Baseline and 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. |
| Secondary | Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | Baseline and Week 26 | 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. |
| Secondary | Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26 | Baseline and 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. |
| Secondary | Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26 | Baseline and 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. |
| Secondary | Change From Baseline in Echocardiographic Left Ventricular Size at Week 26 | Baseline and 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. |
| Secondary | Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder | Baseline up to Week 26 | |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline up to Week 26 | 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. |
| Secondary | Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26 | Baseline and 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26 | Baseline and Week 26 | ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Percent change | MEAN |
| SECONDARY | Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | Baseline and Week 26 | ITT population included all the randomized participants who had at least one dose of the investigational product. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26 | Baseline and Week 26 | ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Meter | MEAN |
| SECONDARY | Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26 | Baseline and Week 26 | ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Percent LVEF | MEAN |
| SECONDARY | Change From Baseline in Echocardiographic Left Ventricular Size at Week 26 | Baseline and Week 26 | ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Milliliter LVID | MEAN |
| SECONDARY | Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder | Baseline up to Week 26 | ITT population included all the randomized participants who had at least one dose of the investigational product. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Baseline up to Week 26 | Safety analysis population included all the randomized participants who had at least one dose of the investigational product had post-dose safety data confirmed at least once by the Investigator. | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26 | Baseline and Week 26 | ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26 | Low Dose Bisoprolol | 8.02 | Standard Deviation 113.78 | Percent change | |
| Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26 | High Dose Bisoprolol | 9.50 | Standard Deviation 117.56 | Percent change | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | Low Dose Bisoprolol | Baseline: Class II | 73.08 | Percentage of participants | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | High Dose Bisoprolol | Baseline: Class II | 74.77 | Percentage of participants | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | Low Dose Bisoprolol | Baseline: Class III | 25.00 | Percentage of participants | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | High Dose Bisoprolol | Baseline: Class III | 24.30 | Percentage of participants | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | Low Dose Bisoprolol | Baseline: Class IV | 1.92 | Percentage of participants | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | High Dose Bisoprolol | Baseline: Class IV | 0.93 | Percentage of participants | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | Low Dose Bisoprolol | Week 26: Class I | 21.15 | Percentage of participants | |
| Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) | High Dose Bisoprolol | Week 26: Class I | 42.06 | Percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose Bisoprolol | 66 | |
| Overall Study | STARTED | High Dose Bisoprolol | 114 | |
| Overall Study | COMPLETED | Low Dose Bisoprolol | 44 | |
| Overall Study | COMPLETED | High Dose Bisoprolol | 102 | |
| Overall Study | NOT COMPLETED | Low Dose Bisoprolol | 22 | |
| Overall Study | NOT COMPLETED | High Dose Bisoprolol | 12 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Low Dose Bisoprolol | 8 | 66 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | High Dose Bisoprolol | 11 | 114 | |
| other | Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Low Dose Bisoprolol | 3 | 66 | |
| other | Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | High Dose Bisoprolol | 3 | 114 | |
| other | Cardiac failure | Cardiac disorders | Low Dose Bisoprolol | 1 | 66 | |
| other | Cardiac failure | Cardiac disorders | High Dose Bisoprolol | 4 | 114 | |
| other | Hypotension | Vascular disorders | Low Dose Bisoprolol | 3 | 66 | |
| other | Hypotension | Vascular disorders | High Dose Bisoprolol | 4 | 114 | |
| other | Diarrhoea | Gastrointestinal disorders | Low Dose Bisoprolol | 0 | 66 | |
| other | Diarrhoea | Gastrointestinal disorders | High Dose Bisoprolol | 4 | 114 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Bisoprolol | ||
| Total, all-cause mortality | High Dose Bisoprolol | ||
| Total, other adverse events | Low Dose Bisoprolol | 45 | 66 |
| Total, other adverse events | High Dose Bisoprolol | 71 | 114 |
| Total, serious adverse events | Low Dose Bisoprolol | 16 | 66 |
| Total, serious adverse events | High Dose Bisoprolol | 9 | 114 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low Dose Bisoprolol vs High Dose Bisoprolol: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Low Dose Bisoprolol vs High Dose Bisoprolol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01074307
GET https://conductscience.org/api/trials/v1/NCT01074307/results?page=2