Chronic Heart Failure
Conditions
Keywords
Bisoprolol, Chronic Heart failure
Brief 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 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.
Interventions
DRUGBisoprolol
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.
Sponsors
Merck Ltd.
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \>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%
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | 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 | 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 | 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 | Baseline and Week 26 (or EOT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline and 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. |
| Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline and 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. |
| Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline and 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. |
| Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline and 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. |
| 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 | Baseline and 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. |
| Number of Participants With Hospitalization Due to Heart Failure | Baseline to Week 26 (or EOT) | — |
| Duration of Hospitalization Due to Heart Failure | 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 | Baseline and 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. |
Countries
South Korea
Participant flow
Pre-assignment details
A total of 117 participants were screened for the study, out of which 17 were screen failures and 100 participants received the study medication.
Participants by arm
| Arm | Count |
|---|---|
| Bisoprolol Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missing of genetic analysis results | 1 |
| Overall Study | Missing of primary efficacy assessment | 10 |
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Bisoprolol |
|---|---|
| Age, Continuous | 56.05 years STANDARD_DEVIATION 13.43 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 93 / 100 |
| serious Total, serious adverse events | 7 / 100 |
Outcome results
Primary
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)
Population: Efficacy intention to treat (ITT) population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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) | Change at Week 26 or EOT: Gly389Gly (n= 5) | -9.20 Percent LVEF | Standard Deviation 5.63 |
| Bisoprolol | 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) | Baseline: Arg389Arg (n= 53) | 32.44 Percent LVEF | Standard Deviation 7.84 |
| Bisoprolol | 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) | Baseline: Arg389Gly (n= 25) | 32.89 Percent LVEF | Standard Deviation 7.7 |
| Bisoprolol | 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) | Baseline: Gly389Gly (n= 5) | 32.20 Percent LVEF | Standard Deviation 6.83 |
| Bisoprolol | 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) | Change at Week 26 or EOT: Arg389Arg (n= 53) | -8.44 Percent LVEF | Standard Deviation 9 |
| Bisoprolol | 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) | Change at Week 26 or EOT: Arg389Gly (n= 25) | -9.36 Percent LVEF | Standard Deviation 7.62 |
Primary
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)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Gly16Gly (n= 28) | 33.03 Percent LVEF | Standard Deviation 7.35 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Arg16Arg (n= 14) | 31.31 Percent LVEF | Standard Deviation 8.97 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Arg16Gly (n= 41) | 32.67 Percent LVEF | Standard Deviation 7.55 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Arg16Arg (n= 14) | -9.39 Percent LVEF | Standard Deviation 8.49 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Arg16Gly (n= 41) | -7.87 Percent LVEF | Standard Deviation 8.94 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Gly16Gly (n= 28) | -9.76 Percent LVEF | Standard Deviation 7.57 |
Primary
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)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Glu27Glu (n= 1) | 38.00 Percent LVEF | — |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Glu27Gln (n= 15) | 33.01 Percent LVEF | Standard Deviation 7.3 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Gln27Gln (n= 67) | 32.38 Percent LVEF | Standard Deviation 7.82 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Glu27Glu (n= 1) | -13.00 Percent LVEF | — |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Glu27Gln (n= 15) | -8.71 Percent LVEF | Standard Deviation 5.73 |
| Bisoprolol | Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Gln27Gln (n= 67) | -8.71 Percent LVEF | Standard Deviation 8.94 |
Primary
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)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: GRK5-Arg304 (n= 50) | 32.37 Percent LVEF | Standard Deviation 7.81 |
| Bisoprolol | 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 | Baseline: GRK5-Arg304His (n= 30) | 33.14 Percent LVEF | Standard Deviation 7.46 |
| Bisoprolol | 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 | Baseline: GRK5-His304 (n= 3) | 29.87 Percent LVEF | Standard Deviation 9.33 |
| Bisoprolol | 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 | Change at Week 26 or EOT: GRK5-His304 (n= 3) | -12.47 Percent LVEF | Standard Deviation 13.27 |
| Bisoprolol | 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 | Change at Week 26 or EOT: GRK5-Arg304 (n= 50) | -7.69 Percent LVEF | Standard Deviation 7.73 |
| Bisoprolol | 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 | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | -10.19 Percent LVEF | Standard Deviation 8.93 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 53) | 401.36 Meter | Standard Deviation 161.88 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 53) | -20.85 Meter | Standard Deviation 89.52 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | -0.90 Meter | Standard Deviation 93.04 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | -20.10 Meter | Standard Deviation 27.35 |
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 24) | 381.71 Meter | Standard Deviation 172.47 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 371.70 Meter | Standard Deviation 128.16 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 395.11 Meter | Standard Deviation 173.68 |
| Bisoprolol | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 431.67 Meter | Standard Deviation 42.52 |
| Bisoprolol | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 49) | -13.86 Meter | Standard Deviation 79.64 |
| Bisoprolol | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | -17.61 Meter | Standard Deviation 104.93 |
| Bisoprolol | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | -6.67 Meter | Standard Deviation 25.66 |
| Bisoprolol | Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 49) | 390.68 Meter | Standard Deviation 160.61 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Gly16Gly (n= 27) | 333.19 Meter | Standard Deviation 179.71 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Arg16Arg (n= 14) | 0.46 Meter | Standard Deviation 56.91 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Arg16Gly (n= 41) | -12.18 Meter | Standard Deviation 73.57 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Gly16Gly (n= 27) | -27.20 Meter | Standard Deviation 117.54 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Arg16Arg (n= 14) | 449.43 Meter | Standard Deviation 109.9 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Arg16Gly (n= 41) | 414.73 Meter | Standard Deviation 155.27 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Glu27Glu (n= 1) | 468.00 Meter | — |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Glu27Gln (n= 15) | 404.63 Meter | Standard Deviation 175.65 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Gln27Gln (n= 66) | 390.22 Meter | Standard Deviation 160.83 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Glu27Glu (n= 1) | -57.00 Meter | — |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Glu27Gln (n= 15) | 12.23 Meter | Standard Deviation 106.68 |
| Bisoprolol | Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Gln27Gln (n= 66) | -20.51 Meter | Standard Deviation 83.33 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 52) | -0.04 mmHg | Standard Deviation 13.66 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | 3.63 mmHg | Standard Deviation 11.86 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | 1.00 mmHg | Standard Deviation 14.04 |
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 52) | 80.15 mmHg | Standard Deviation 13.62 |
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 24) | 80.50 mmHg | Standard Deviation 12.6 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 81.80 mmHg | Standard Deviation 8.5 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg16Arg (n= 14) | 86.14 mmHg | Standard Deviation 18.92 |
| Bisoprolol | 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 | Baseline: Arg16Gly (n= 41) | 79.66 mmHg | Standard Deviation 11.67 |
| Bisoprolol | 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 | Baseline: Gly16Gly (n= 26) | 78.35 mmHg | Standard Deviation 10.44 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Arg (n= 14) | 4.21 mmHg | Standard Deviation 18.73 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Gly (n= 41) | -0.54 mmHg | Standard Deviation 10.51 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly16Gly (n= 26) | 2.04 mmHg | Standard Deviation 13.44 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Gln (n= 15) | 0.87 mmHg | Standard Deviation 10.78 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gln27Gln (n= 65) | 1.51 mmHg | Standard Deviation 13.48 |
| Bisoprolol | 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 | Baseline: Glu27Glu (n= 1) | 65.00 mmHg | — |
| Bisoprolol | 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 | Baseline: Glu27Gln (n= 15) | 77.40 mmHg | Standard Deviation 6.31 |
| Bisoprolol | 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 | Baseline: Gln27Gln (n= 65) | 81.28 mmHg | Standard Deviation 13.94 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Glu (n= 1) | -21.00 mmHg | — |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 48) | 79.10 mmHg | Standard Deviation 11.08 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 81.97 mmHg | Standard Deviation 15.98 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 84.33 mmHg | Standard Deviation 4.04 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 48) | 0.79 mmHg | Standard Deviation 13.46 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | 1.27 mmHg | Standard Deviation 13.31 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | 4.67 mmHg | Standard Deviation 5.51 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg16Gly (n= 41) | 75.59 mmHg | Standard Deviation 11.11 |
| Bisoprolol | 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 | Baseline: Gly16Gly (n= 26) | 74.85 mmHg | Standard Deviation 9.79 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Arg (n= 14) | 4.07 mmHg | Standard Deviation 18.89 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Gly (n= 41) | -0.88 mmHg | Standard Deviation 10.39 |
| Bisoprolol | 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 | Baseline: Arg16Arg (n= 14) | 83.14 mmHg | Standard Deviation 22.76 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly16Gly (n= 26) | -0.23 mmHg | Standard Deviation 14.71 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Glu27Glu (n= 1) | 68.00 mmHg | — |
| Bisoprolol | 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 | Baseline: Glu27Gln (n= 15) | 71.80 mmHg | Standard Deviation 8.9 |
| Bisoprolol | 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 | Baseline: Gln27Gln (n= 65) | 77.91 mmHg | Standard Deviation 14.33 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Glu (n= 1) | -28.00 mmHg | — |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Gln (n= 15) | -1.93 mmHg | Standard Deviation 11.22 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gln27Gln (n= 65) | 1.11 mmHg | Standard Deviation 13.66 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 48) | 74.90 mmHg | Standard Deviation 10.79 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 78.87 mmHg | Standard Deviation 17.43 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 82.67 mmHg | Standard Deviation 7.02 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 48) | 0.06 mmHg | Standard Deviation 12.93 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | -0.13 mmHg | Standard Deviation 15.17 |
| Bisoprolol | Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | 5.33 mmHg | Standard Deviation 1.15 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | 0.29 mmHg | Standard Deviation 15.16 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | 0.60 mmHg | Standard Deviation 11.7 |
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 52) | 75.69 mmHg | Standard Deviation 14.7 |
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 24) | 78.17 mmHg | Standard Deviation 12.33 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 79.40 mmHg | Standard Deviation 5.55 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 52) | 0.10 mmHg | Standard Deviation 13.13 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 53) | 92.02 bpm | Standard Deviation 19.82 |
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 24) | 90.92 bpm | Standard Deviation 21.37 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 92.80 bpm | Standard Deviation 25.99 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 53) | 11.83 bpm | Standard Deviation 17.83 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | 4.60 bpm | Standard Deviation 15.79 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | 15.88 bpm | Standard Deviation 16.54 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg16Arg (n= 14) | 87.86 bpm | Standard Deviation 18.53 |
| Bisoprolol | 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 | Baseline: Arg16Gly (n= 41) | 95.05 bpm | Standard Deviation 21.41 |
| Bisoprolol | 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 | Baseline: Gly16Gly (n= 27) | 88.74 bpm | Standard Deviation 19.55 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Arg (n= 14) | 11.21 bpm | Standard Deviation 15.34 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Gly (n= 41) | 12.37 bpm | Standard Deviation 18.83 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly16Gly (n= 27) | 13.59 bpm | Standard Deviation 16.57 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Glu27Glu (n= 1) | 90.00 bpm | — |
| Bisoprolol | 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 | Baseline: Glu27Gln (n= 15) | 84.40 bpm | Standard Deviation 15.89 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gln27Gln (n= 66) | 13.45 bpm | Standard Deviation 18.24 |
| Bisoprolol | 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 | Baseline: Gln27Gln (n= 66) | 93.44 bpm | Standard Deviation 21.16 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Glu (n= 1) | -3.00 bpm | — |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Gln (n= 15) | 9.73 bpm | Standard Deviation 13.1 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 49) | 92.41 bpm | Standard Deviation 20.87 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 89.30 bpm | Standard Deviation 19.18 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 105.33 bpm | Standard Deviation 25.7 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 49) | 14.59 bpm | Standard Deviation 16.16 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | 8.53 bpm | Standard Deviation 19.39 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | 20.00 bpm | Standard Deviation 8.54 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | 11.79 Beats per minute (bpm) | Standard Deviation 15.13 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | 12.00 Beats per minute (bpm) | Standard Deviation 22.55 |
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 53) | 76.47 Beats per minute (bpm) | Standard Deviation 12.9 |
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 24) | 82.25 Beats per minute (bpm) | Standard Deviation 14.66 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 83.20 Beats per minute (bpm) | Standard Deviation 19.52 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 53) | 8.91 Beats per minute (bpm) | Standard Deviation 14.8 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg16Arg (n= 14) | 79.21 bpm | Standard Deviation 13.96 |
| Bisoprolol | 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 | Baseline: Arg16Gly (n= 41) | 79.02 bpm | Standard Deviation 15.06 |
| Bisoprolol | 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 | Baseline: Gly16Gly (n= 27) | 77.56 bpm | Standard Deviation 12.61 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Arg (n= 14) | 13.21 bpm | Standard Deviation 12.71 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Gly (n= 41) | 9.20 bpm | Standard Deviation 13.88 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly16Gly (n= 27) | 9.37 bpm | Standard Deviation 18.45 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Gln27Gln (n= 66) | 78.82 bpm | Standard Deviation 14.52 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Glu (n= 1) | 9.00 bpm | — |
| Bisoprolol | 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 | Baseline: Glu27Glu (n= 1) | 92.00 bpm | — |
| Bisoprolol | 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 | Baseline: Glu27Gln (n= 15) | 76.60 bpm | Standard Deviation 11.47 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Gln (n= 15) | 10.33 bpm | Standard Deviation 15.77 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gln27Gln (n= 66) | 9.86 bpm | Standard Deviation 15.37 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 49) | 77.29 bpm | Standard Deviation 12.29 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 80.80 bpm | Standard Deviation 16.54 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 77.33 bpm | Standard Deviation 13.32 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 49) | 10.92 bpm | Standard Deviation 13 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | 7.83 bpm | Standard Deviation 18.69 |
| Bisoprolol | Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | 15.00 bpm | Standard Deviation 13 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Arg16Arg (n= 14) | 2809.30 pg/mL | Standard Deviation 5763.28 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Arg16Gly (n= 41) | 823.71 pg/mL | Standard Deviation 809.39 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Arg16Arg (n= 14) | 1600.88 pg/mL | Standard Deviation 4294.99 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Arg16Gly (n= 40) | -33.98 pg/mL | Standard Deviation 909.74 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Change at Week 26 or EOT: Gly16Gly (n= 28) | 137.68 pg/mL | Standard Deviation 901.46 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT | Baseline: Gly16Gly (n= 28) | 1139.07 pg/mL | Standard Deviation 1691.51 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Glu27Glu (n= 1) | 120.80 pg/mL | — |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Glu27Gln (n= 15) | 878.31 pg/mL | Standard Deviation 919.99 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Baseline: Gln27Gln (n= 67) | 1368.67 pg/mL | Standard Deviation 2915.35 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Glu27Glu (n= 1) | 84.91 pg/mL | — |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Glu27Gln (n= 15) | 131.60 pg/mL | Standard Deviation 902.5 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT | Change at Week 26 or EOT: Gln27Gln (n= 66) | 346.20 pg/mL | Standard Deviation 2187.04 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 50) | 895.52 pg/mL | Standard Deviation 1291.9 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 1854.63 pg/mL | Standard Deviation 4030.43 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 1527.09 pg/mL | Standard Deviation 1836.19 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | 799.31 pg/mL | Standard Deviation 3052.03 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | 861.39 pg/mL | Standard Deviation 1450.04 |
| Bisoprolol | Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 49) | -33.78 pg/mL | Standard Deviation 850.25 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 53) | 1484.02 picograms (pg)/ milliliter (mL) | Standard Deviation 3258.55 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 1011.30 picograms (pg)/ milliliter (mL) | Standard Deviation 558.49 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 53) | 292.10 picograms (pg)/ milliliter (mL) | Standard Deviation 2452.11 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | 394.32 picograms (pg)/ milliliter (mL) | Standard Deviation 407.89 |
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 25) | 851.47 picograms (pg)/ milliliter (mL) | Standard Deviation 830.19 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | 310.63 picograms (pg)/ milliliter (mL) | Standard Deviation 643.97 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 52) | 128.77 mmHg | Standard Deviation 20.95 |
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 24) | 130.25 mmHg | Standard Deviation 22.55 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 128.60 mmHg | Standard Deviation 14.52 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 52) | -2.92 mmHg | Standard Deviation 18.24 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | -0.46 mmHg | Standard Deviation 22.31 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | 5.40 mmHg | Standard Deviation 23.64 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg16Arg (n= 14) | 138.71 mmHg | Standard Deviation 25.63 |
| Bisoprolol | 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 | Baseline: Arg16Gly (n= 41) | 126.56 mmHg | Standard Deviation 19.78 |
| Bisoprolol | 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 | Baseline: Gly16Gly (n= 26) | 128.23 mmHg | Standard Deviation 19.19 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Arg (n= 14) | 3.29 mmHg | Standard Deviation 17.79 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Gly (n= 41) | -4.34 mmHg | Standard Deviation 20.96 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly16Gly (n= 26) | -0.15 mmHg | Standard Deviation 18.59 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Glu27Glu (n= 1) | 113.00 mmHg | — |
| Bisoprolol | 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 | Baseline: Glu27Gln (n= 15) | 124.47 mmHg | Standard Deviation 9.62 |
| Bisoprolol | 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 | Baseline: Gln27Gln (n= 65) | 130.54 mmHg | Standard Deviation 22.69 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Glu (n= 1) | -18.00 mmHg | — |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gln27Gln (n= 65) | -0.68 mmHg | Standard Deviation 21.03 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Gln (n= 15) | -4.93 mmHg | Standard Deviation 12.61 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 48) | 127.52 mmHg | Standard Deviation 17.67 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 131.27 mmHg | Standard Deviation 25.87 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 135.33 mmHg | Standard Deviation 16.04 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 48) | -2.10 mmHg | Standard Deviation 20.08 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | -2.37 mmHg | Standard Deviation 19.51 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | 12.00 mmHg | Standard Deviation 15.1 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg16Arg (n= 14) | 132.36 mmHg | Standard Deviation 27.18 |
| Bisoprolol | 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 | Baseline: Arg16Gly (n= 41) | 117.83 mmHg | Standard Deviation 14.61 |
| Bisoprolol | 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 | Baseline: Gly16Gly (n= 26) | 123.15 mmHg | Standard Deviation 14.22 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Arg (n= 14) | 2.50 mmHg | Standard Deviation 15.62 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg16Gly (n= 41) | -4.32 mmHg | Standard Deviation 15.69 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly16Gly (n= 26) | 0.92 mmHg | Standard Deviation 16.43 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Glu27Glu (n= 1) | 130.00 mmHg | — |
| Bisoprolol | 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 | Baseline: Glu27Gln (n= 15) | 115.53 mmHg | Standard Deviation 11.55 |
| Bisoprolol | 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 | Baseline: Gln27Gln (n= 65) | 123.43 mmHg | Standard Deviation 18.85 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Glu (n= 1) | -13.00 mmHg | — |
| Bisoprolol | 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 | Change at Week 26 or EOT: Glu27Gln (n= 15) | -4.33 mmHg | Standard Deviation 12.31 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gln27Gln (n= 65) | -0.62 mmHg | Standard Deviation 16.79 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-His304 (n= 3) | 127.33 mmHg | Standard Deviation 16.17 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304 (n= 48) | -2.25 mmHg | Standard Deviation 15.86 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-Arg304His (n= 30) | -1.13 mmHg | Standard Deviation 16.78 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Change at Week 26 or EOT: GRK5-His304 (n= 3) | 8.00 mmHg | Standard Deviation 9.64 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304 (n= 48) | 118.92 mmHg | Standard Deviation 13.79 |
| Bisoprolol | Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT | Baseline: GRK5-Arg304His (n= 30) | 126.53 mmHg | Standard Deviation 22.61 |
Secondary
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.
Time frame: Baseline and Week 26 (or EOT)
Population: Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bisoprolol | 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 | Baseline: Arg389Gly (n= 24) | 123.54 millimeters of mercury (mmHg) | Standard Deviation 15.91 |
| Bisoprolol | 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 | Baseline: Gly389Gly (n= 5) | 117.40 millimeters of mercury (mmHg) | Standard Deviation 15.09 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Arg (n= 52) | -0.96 millimeters of mercury (mmHg) | Standard Deviation 15.09 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Arg389Gly (n= 24) | -2.75 millimeters of mercury (mmHg) | Standard Deviation 16.54 |
| Bisoprolol | 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 | Change at Week 26 or EOT: Gly389Gly (n= 5) | -0.40 millimeters of mercury (mmHg) | Standard Deviation 25.07 |
| Bisoprolol | 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 | Baseline: Arg389Arg (n= 52) | 121.81 millimeters of mercury (mmHg) | Standard Deviation 19.07 |
Secondary
Duration of Hospitalization Due to Heart Failure
Time frame: Baseline to Week 26 (or EOT)
Population: Participant analyzed included 1 participant from the efficacy ITT population who was hospitalized once due to heart failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bisoprolol | Duration of Hospitalization Due to Heart Failure | 41 Days |
Secondary
Number of Participants With Hospitalization Due to Heart Failure
Time frame: Baseline to Week 26 (or EOT)
Population: Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bisoprolol | Number of Participants With Hospitalization Due to Heart Failure | 1 Participants |