Phase 4
Completed N=180
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
Heart Failure, Congestive
Source: ClinicalTrials.gov NCT01074307 ↗
Enrolled (actual)
180
Serious AEs
13.9%
Results posted
Feb 2014
Primary outcomePrimary: Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26 — 8.02; 9.50 Percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26 |
8.02; 9.50 | — |
| SECONDARY Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA) |
73.08; 74.77; 25.00; 24.30; 1.92; 0.93 | — |
| SECONDARY Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26 |
347.58; 368.11; 41.59; 28.45 | — |
| SECONDARY Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26 |
28.68; 27.61; 8.83; 14.22 | — |
| SECONDARY Change From Baseline in Echocardiographic Left Ventricular Size at Week 26 |
54.25; 54.69; 5.46; 9.84; 64.28; 63.40 | — |
| SECONDARY Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder |
3; 3; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
45; 73 | — |
| SECONDARY Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26 |
2.52; 2.71; 0.45; 0.69 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 ( 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
- 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
Data sourced from ClinicalTrials.gov (NCT01074307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.