Chronic Heart FailurePhase 4ABBANCT01104558
Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.
A Phase 4 study testing Bisoprolol in people with Chronic Heart Failure, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.
Trial summary
At present, there is some clinical data for different functional response to beta-blockers associated with beta-adrenergic receptor polymorphisms. But there has been no data reported, about the incidence of beta-adrenergic receptor polymorphism and association with beta-adrenergic receptor polymorphism and response to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Bisoprolol
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Jul 2010
- 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
- >18 years of age and <80 years of age
- Chronic heart failure subjects with stable clinical condition
- New York Heart Association (NYHA) functional classification II-III
- Left ventricular ejection fraction (LVEF) ≤45%
Who cannot join
- NYHA functional classification IV
- Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft, Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months
- Hypersensitivity to bisoprolol or any of the Concor excipients
- Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary insufficiency
- Systolic Blood Pressure <90 millimeters of mercury (mmHg) at screening
- Resting Heart Rate <55 beats per minute (bpm) confirmed by electrocardiogram (ECG) at screening
- Subjects who are taking concomitant drug which can have drug-drug interaction (DDI) with bisoprolol
- Woman of childbearing age without effective contraception measures, or who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St. Mary's Hospital, 505, Banpodong, SeoChoGu
Seoul
About this study
Official title: Association Between Beta-1 and Beta-2 Adrenergic Receptor Polymorphism and Beta-blocker (Bisoprolol) Therapy in Heart Failure
At present, there is some clinical data for different functional response to beta-blockers associated with beta-adrenergic receptor polymorphisms. But there has been no data reported, about the incidence of beta-adrenergic receptor polymorphism and association with beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects.
Read the detailed description
Heart failure impairs the quality of life of an individual and is considered to be the main cause of morbidity and mortality. Prognosis of HF subjects depends on severity, age and sex. Subjects with HF require lifelong treatment. Pharmacological treatment aims to improve both the quality of life and survival of HF subjects.
OBJECTIVES:
Primary objective:
- To analyze the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects
Secondary objective:
- The frequency of polymorphism of beta adrenergic receptor in Korean HF subjects
- To evaluate change from baseline in 6-minute walking test, heart rate (HR), blood pressure (BP), pro B-type natriuretic peptide (BNP) level at week 26 or End of Treatment (EOT)
- To compare frequency and duration of hospitalization due to heart failure
The method involved in this study will be as follows:
- Initial evaluation of HF subjects
- Blood genomic deoxyribonucleic acid (DNA) isolation and collection
- Bisoprolol treatment as add on therapy with standard treatment for HF subject for 6 months
- Genotype of beta adrenergic receptor polymorphism
- Follow up evaluation of treated subjects
Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.
- Conditions
- Chronic Heart Failure
- Being tested
- Bisoprolol
- Keywords
- Bisoprolol, Chronic Heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Also called Concor
Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT)
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT
Measured: Baseline and Week 26 (or EOT)
Secondary outcomes (34)
Number of Participants With Hospitalization Due to Heart Failure
Measured: Baseline to Week 26 (or EOT)
Duration of Hospitalization Due to Heart Failure
Measured: Baseline to Week 26 (or EOT)
Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
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 (or EOT)
Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
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 (or EOT)
Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
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 (or EOT)
Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
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 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
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.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
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.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
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.
Measured: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
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.
Measured: Baseline and Week 26 (or EOT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startDec 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104558
- Sponsor's protocol ID
- EMD084000-500
- Acronym
- ABBA
- Status last verified
- Jan 2014
- First submitted
- 24 Feb 2010
- Last updated
- 13 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Beta-1 and Beta-2 Adrenergic Receptor Polymorphism and Beta-blocker (Bisoprolol) Therapy in Heart Failure
- ClinicalTrials.gov ID
- NCT01104558
- Acronym / sponsor ID
- ABBA / EMD084000-500
- Conditions
- Chronic Heart Failure
- Keywords
- Bisoprolol, Chronic Heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd.
- Study start
- Dec 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Posted 10 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, there is some clinical data for different functional response to beta-blockers associated with beta-adrenergic receptor polymorphisms. But there has been no data reported, about the incidence of beta-adrenergic receptor polymorphism and association with beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects.
Detailed description
Heart failure impairs the quality of life of an individual and is considered to be the main cause of morbidity and mortality. Prognosis of HF subjects depends on severity, age and sex. Subjects with HF require lifelong treatment. Pharmacological treatment aims to improve both the quality of life and survival of HF subjects.
OBJECTIVES:
Primary objective:
- To analyze the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects
Secondary objective:
- The frequency of polymorphism of beta adrenergic receptor in Korean HF subjects
- To evaluate change from baseline in 6-minute walking test, heart rate (HR), blood pressure (BP), pro B-type natriuretic peptide (BNP) level at week 26 or End of Treatment (EOT)
- To compare frequency and duration of hospitalization due to heart failure
The method involved in this study will be as follows:
- Initial evaluation of HF subjects
- Blood genomic deoxyribonucleic acid (DNA) isolation and collection
- Bisoprolol treatment as add on therapy with standard treatment for HF subject for 6 months
- Genotype of beta adrenergic receptor polymorphism
- Follow up evaluation of treated subjects
Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age and <80 years of age
- Chronic heart failure subjects with stable clinical condition
- New York Heart Association (NYHA) functional classification II-III
- Left ventricular ejection fraction (LVEF) ≤45%
Key exclusion criteria (8 listed)
- NYHA functional classification IV
- Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft, Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months
- Hypersensitivity to bisoprolol or any of the Concor excipients
- Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary insufficiency
- Systolic Blood Pressure <90 millimeters of mercury (mmHg) at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BisoprololAlso: ConcorBisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose. | Drug | – |
Primary outcome
Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT)
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
34 secondary outcomes
Number of Participants With Hospitalization Due to Heart Failure
Time frame: Baseline to Week 26 (or EOT)
Duration of Hospitalization Due to Heart Failure
Time frame: Baseline to Week 26 (or EOT)
Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT
Time frame: Baseline and Week 26 (or EOT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisoprolol in people with Chronic Heart Failure, 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 8 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 13 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 10 Apr 2012). 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?
Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT) (time frame: Baseline and Week 26 (or EOT)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2014.