Heart Failure
Conditions
Keywords
Chronic Heart Failure, Heart Failure with Reduced Ejection Fraction
Brief summary
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
Interventions
5 mg orally once daily for 20 weeks
DRUGPlacebo
Orally once daily for 20 weeks
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18 years and older * Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP
Exclusion criteria
* Acute de-novo heart failure * Requirement of any intravenous (IV) treatments following 48 hours prior to randomization * Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) * Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography | Baseline, Week 20 | Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported. |
| Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 | Baseline, Week 20 | NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 | Baseline, Week 20 | High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported. |
| Number of Participants With Composite Efficacy Outcome | Baseline up to Week 26 | Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported. |
| Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 | Baseline, Week 20 | LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported. |
| Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) | Baseline up to Week 26 | Number of participants with HF hospitalization and urgent visits for HF were reported. |
| Number of Participants With Cardiovascular (CV) Mortality | Baseline up to Week 26 | Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported. |
| Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 | Baseline, Week 20 | LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported. |
Countries
Belgium, Bulgaria, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Spain, United States
Participant flow
Recruitment details
Study was conducted at multiple centers in 11 countries between 22 February 2017 (first participant first visit) and 16 May 2018 (last participant last visit).
Pre-assignment details
Overall, 462 participants were screened. Of them, 35 participants did not complete screening due to unmet eligibility criteria, consent withdrawal, adverse events and other unspecified reasons. In total, 427 participants were randomized and 426 participants received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks. | 106 |
| Neladenoson Bialanate 5 mg Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks. | 37 |
| Neladenoson Bialanate 10 mg Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks. | 70 |
| Neladenoson Bialanate 20 mg Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks. | 73 |
| Neladenoson Bialanate 30 mg Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks. | 69 |
| Neladenoson Bialanate 40 mg Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks. | 72 |
| Total | 427 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 2 | 2 | 2 | 2 | 7 |
| Overall Study | Death | 2 | 0 | 2 | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Non-compliance with study drug | 0 | 1 | 1 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 3 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 | 5 | 3 | 4 |
Baseline characteristics
| Characteristic | Placebo | Neladenoson Bialanate 5 mg | Neladenoson Bialanate 10 mg | Neladenoson Bialanate 20 mg | Neladenoson Bialanate 30 mg | Neladenoson Bialanate 40 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 66.9 Years STANDARD_DEVIATION 9.4 | 66.6 Years STANDARD_DEVIATION 10.5 | 66.4 Years STANDARD_DEVIATION 11.2 | 68.1 Years STANDARD_DEVIATION 10 | 67.6 Years STANDARD_DEVIATION 9.8 | 67.5 Years STANDARD_DEVIATION 10 | 67.2 Years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 37 Participants | 69 Participants | 72 Participants | 66 Participants | 72 Participants | 421 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Left ventricular ejection fraction (LVEF) | 28.24 Percentage of LVEF STANDARD_DEVIATION 10.67 | 26.22 Percentage of LVEF STANDARD_DEVIATION 7.99 | 27.58 Percentage of LVEF STANDARD_DEVIATION 8.92 | 29.70 Percentage of LVEF STANDARD_DEVIATION 10.87 | 29.87 Percentage of LVEF STANDARD_DEVIATION 11.54 | 26.24 Percentage of LVEF STANDARD_DEVIATION 8.92 | 28.18 Percentage of LVEF STANDARD_DEVIATION 10.17 |
| Medical history: Atrial fibrillation With Atrial fibrillation | 44 Participants | 14 Participants | 27 Participants | 26 Participants | 27 Participants | 33 Participants | 171 Participants |
| Medical history: Atrial fibrillation Without Atrial fibrillation | 62 Participants | 23 Participants | 43 Participants | 47 Participants | 42 Participants | 39 Participants | 256 Participants |
| Medical history: Chronic heart failure etiology Ischemic | 65 Participants | 25 Participants | 45 Participants | 50 Participants | 37 Participants | 42 Participants | 264 Participants |
| Medical history: Chronic heart failure etiology Missing | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Medical history: Chronic heart failure etiology Non-ischemic | 41 Participants | 12 Participants | 24 Participants | 23 Participants | 32 Participants | 30 Participants | 162 Participants |
| Medication of interest: Angiotensin-converting enzyme inhibitor Angiotensin-converting enzyme inhibitor | 58 Participants | 19 Participants | 41 Participants | 41 Participants | 36 Participants | 45 Participants | 240 Participants |
| Medication of interest: Angiotensin-converting enzyme inhibitor Not used at baseline | 48 Participants | 18 Participants | 29 Participants | 32 Participants | 33 Participants | 27 Participants | 187 Participants |
| Medication of interest: Angiotensin receptor blocker Angiotensin receptor blocker | 15 Participants | 6 Participants | 11 Participants | 14 Participants | 9 Participants | 9 Participants | 64 Participants |
| Medication of interest: Angiotensin receptor blocker Not used at baseline | 91 Participants | 31 Participants | 59 Participants | 59 Participants | 60 Participants | 63 Participants | 363 Participants |
| Medication of interest: Angiotensin receptor-neprilysin inhibitor Angiotensin receptor-neprilysin inhibitor | 20 Participants | 7 Participants | 9 Participants | 9 Participants | 12 Participants | 12 Participants | 69 Participants |
| Medication of interest: Angiotensin receptor-neprilysin inhibitor Not used at baseline | 86 Participants | 30 Participants | 61 Participants | 64 Participants | 57 Participants | 60 Participants | 358 Participants |
| Medication of interest: Beta-blocker Beta-blocker | 103 Participants | 37 Participants | 66 Participants | 70 Participants | 67 Participants | 69 Participants | 412 Participants |
| Medication of interest: Beta-blocker Not used at baseline | 3 Participants | 0 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 15 Participants |
| Medication of interest: Mineralocorticoid receptor antagonist Mineralocorticoid receptor antagonist | 93 Participants | 33 Participants | 56 Participants | 60 Participants | 56 Participants | 57 Participants | 355 Participants |
| Medication of interest: Mineralocorticoid receptor antagonist Not used at baseline | 13 Participants | 4 Participants | 14 Participants | 13 Participants | 13 Participants | 15 Participants | 72 Participants |
| New York Heart Association (NYHA) Class Class I | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| New York Heart Association (NYHA) Class Class II | 62 Participants | 23 Participants | 38 Participants | 44 Participants | 49 Participants | 49 Participants | 265 Participants |
| New York Heart Association (NYHA) Class Class III/IV | 44 Participants | 14 Participants | 31 Participants | 29 Participants | 20 Participants | 23 Participants | 161 Participants |
| N-terminal pro-hormone b-type natriuretic peptide (NT-proBNP) | 2111.00 Picograms per milliliter (pg/mL) | 2071.00 Picograms per milliliter (pg/mL) | 2063.00 Picograms per milliliter (pg/mL) | 1894.50 Picograms per milliliter (pg/mL) | 2084.00 Picograms per milliliter (pg/mL) | 2419.00 Picograms per milliliter (pg/mL) | 2085.00 Picograms per milliliter (pg/mL) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 3 Participants | 5 Participants | 3 Participants | 5 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 98 Participants | 32 Participants | 65 Participants | 66 Participants | 64 Participants | 65 Participants | 390 Participants |
| Sex: Female, Male Female | 18 Participants | 9 Participants | 11 Participants | 14 Participants | 12 Participants | 7 Participants | 71 Participants |
| Sex: Female, Male Male | 88 Participants | 28 Participants | 59 Participants | 59 Participants | 57 Participants | 65 Participants | 356 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 106 | 1 / 37 | 5 / 70 | 1 / 72 | 2 / 69 | 2 / 72 |
| other Total, other adverse events | 24 / 106 | 10 / 37 | 15 / 70 | 18 / 72 | 24 / 69 | 19 / 72 |
| serious Total, serious adverse events | 31 / 106 | 13 / 37 | 28 / 70 | 22 / 72 | 28 / 69 | 26 / 72 |
Outcome results
Primary
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Time frame: Baseline, Week 20
Population: Per-protocol set (PPS) included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to cardiovascular (CV) death or heart failure (HF) hospitalization or with other major protocol deviation were excluded from PPS LVEF set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography | -2.19 Percentage of LVEF | Standard Deviation 8.39 |
| Neladenoson Bialanate 5 mg | Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography | 2.59 Percentage of LVEF | Standard Deviation 8.48 |
| Neladenoson Bialanate 10 mg | Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography | -3.01 Percentage of LVEF | Standard Deviation 10.43 |
| Neladenoson Bialanate 20 mg | Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography | 0.13 Percentage of LVEF | Standard Deviation 8.74 |
| Neladenoson Bialanate 30 mg | Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography | -2.45 Percentage of LVEF | Standard Deviation 10.54 |
| Neladenoson Bialanate 40 mg | Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography | 1.53 Percentage of LVEF | Standard Deviation 10.01 |
p-value: 0.2297MCP-Mod method
p-value: 0.4409MCP-Mod method
p-value: 0.2842MCP-Mod method
p-value: 0.2534MCP-Mod method
p-value: 0.3842MCP-Mod method
Primary
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
Time frame: Baseline, Week 20
Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 | -0.07 log picograms per milliliter | Standard Deviation 0.7 |
| Neladenoson Bialanate 5 mg | Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 | -0.24 log picograms per milliliter | Standard Deviation 0.9 |
| Neladenoson Bialanate 10 mg | Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 | -0.07 log picograms per milliliter | Standard Deviation 0.52 |
| Neladenoson Bialanate 20 mg | Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 | -0.07 log picograms per milliliter | Standard Deviation 0.56 |
| Neladenoson Bialanate 30 mg | Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 | 0.07 log picograms per milliliter | Standard Deviation 0.55 |
| Neladenoson Bialanate 40 mg | Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 | -0.08 log picograms per milliliter | Standard Deviation 0.79 |
p-value: 0.8966MCP-Mod method
p-value: 0.9233MCP-Mod method
p-value: 0.9296MCP-Mod method
p-value: 0.7357MCP-Mod method
p-value: 0.9083MCP-Mod method
Secondary
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
Time frame: Baseline, Week 20
Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 | 0.13 Picograms per milliliter (pg/mL) | Standard Deviation 9.98 |
| Neladenoson Bialanate 5 mg | Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 | 6.46 Picograms per milliliter (pg/mL) | Standard Deviation 33.04 |
| Neladenoson Bialanate 10 mg | Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 | 3.77 Picograms per milliliter (pg/mL) | Standard Deviation 22.32 |
| Neladenoson Bialanate 20 mg | Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 | 7.43 Picograms per milliliter (pg/mL) | Standard Deviation 37.79 |
| Neladenoson Bialanate 30 mg | Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 | 2.59 Picograms per milliliter (pg/mL) | Standard Deviation 12.9 |
| Neladenoson Bialanate 40 mg | Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 | 7.03 Picograms per milliliter (pg/mL) | Standard Deviation 24.81 |
p-value: 0.9955MCP-Mod method
p-value: 0.9946MCP-Mod method
p-value: 0.9913MCP-Mod method
p-value: 0.9982MCP-Mod method
p-value: 0.9959MCP-Mod method
Secondary
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.
Time frame: Baseline, Week 20
Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 | -13.16 Milliliters (mL) | Standard Deviation 40.23 |
| Neladenoson Bialanate 5 mg | Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 | -21.65 Milliliters (mL) | Standard Deviation 61.96 |
| Neladenoson Bialanate 10 mg | Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 | -12.44 Milliliters (mL) | Standard Deviation 39.84 |
| Neladenoson Bialanate 20 mg | Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 | -5.92 Milliliters (mL) | Standard Deviation 30.89 |
| Neladenoson Bialanate 30 mg | Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 | -11.17 Milliliters (mL) | Standard Deviation 42.32 |
| Neladenoson Bialanate 40 mg | Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 | -19.69 Milliliters (mL) | Standard Deviation 48.38 |
p-value: 0.5703MCP-Mod method
p-value: 0.8253MCP-Mod method
p-value: 0.6506MCP-Mod method
p-value: 0.6923MCP-Mod method
p-value: 0.8036MCP-Mod method
Secondary
Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.
Time frame: Baseline, Week 20
Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 | -5.44 Milliliters (mL) | Standard Deviation 33.29 |
| Neladenoson Bialanate 5 mg | Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 | -21.41 Milliliters (mL) | Standard Deviation 48.13 |
| Neladenoson Bialanate 10 mg | Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 | -2.82 Milliliters (mL) | Standard Deviation 35.12 |
| Neladenoson Bialanate 20 mg | Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 | -4.32 Milliliters (mL) | Standard Deviation 29.73 |
| Neladenoson Bialanate 30 mg | Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 | -3.12 Milliliters (mL) | Standard Deviation 33.96 |
| Neladenoson Bialanate 40 mg | Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 | -15.16 Milliliters (mL) | Standard Deviation 39.65 |
p-value: 0.4596MCP-Mod method
p-value: 0.7859MCP-Mod method
p-value: 0.5562MCP-Mod method
p-value: 0.5338MCP-Mod method
p-value: 0.7303MCP-Mod method
Secondary
Number of Participants With Cardiovascular (CV) Mortality
Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
Time frame: Baseline up to Week 26
Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Cardiovascular (CV) Mortality | 1 Participants |
| Neladenoson Bialanate 5 mg | Number of Participants With Cardiovascular (CV) Mortality | 1 Participants |
| Neladenoson Bialanate 10 mg | Number of Participants With Cardiovascular (CV) Mortality | 3 Participants |
| Neladenoson Bialanate 20 mg | Number of Participants With Cardiovascular (CV) Mortality | 1 Participants |
| Neladenoson Bialanate 30 mg | Number of Participants With Cardiovascular (CV) Mortality | 2 Participants |
| Neladenoson Bialanate 40 mg | Number of Participants With Cardiovascular (CV) Mortality | 1 Participants |
Secondary
Number of Participants With Composite Efficacy Outcome
Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.
Time frame: Baseline up to Week 26
Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Composite Efficacy Outcome | 10 Participants |
| Neladenoson Bialanate 5 mg | Number of Participants With Composite Efficacy Outcome | 4 Participants |
| Neladenoson Bialanate 10 mg | Number of Participants With Composite Efficacy Outcome | 10 Participants |
| Neladenoson Bialanate 20 mg | Number of Participants With Composite Efficacy Outcome | 9 Participants |
| Neladenoson Bialanate 30 mg | Number of Participants With Composite Efficacy Outcome | 7 Participants |
| Neladenoson Bialanate 40 mg | Number of Participants With Composite Efficacy Outcome | 8 Participants |
Secondary
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
Number of participants with HF hospitalization and urgent visits for HF were reported.
Time frame: Baseline up to Week 26
Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) | 10 Participants |
| Neladenoson Bialanate 5 mg | Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) | 4 Participants |
| Neladenoson Bialanate 10 mg | Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) | 9 Participants |
| Neladenoson Bialanate 20 mg | Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) | 8 Participants |
| Neladenoson Bialanate 30 mg | Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) | 5 Participants |
| Neladenoson Bialanate 40 mg | Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) | 8 Participants |