Clinical 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Keywords: Systolic heart failure
Bisoprolol
Concor
Echocardiogram
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Ltd.
First posted: 2010-02-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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 (\<) 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
* 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

Primary outcomes:
measure: Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26
timeFrame: Baseline and Week 26
Secondary outcomes:
measure: Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA)
timeFrame: Baseline and Week 26
measure: Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Echocardiographic Left Ventricular Size at Week 26
timeFrame: Baseline and Week 26
measure: Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder
timeFrame: Baseline up to Week 26
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 26
measure: Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Merck Ltd.
name: Medical Responsible
role: STUDY_DIRECTOR
References: