18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by EchocardiographyPrimary· Baseline, Week 20
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Group
Value
95% CI
Placebo
-2.19
± 8.39
Neladenoson Bialanate 5 mg
2.59
± 8.48
Neladenoson Bialanate 10 mg
-3.01
± 10.43
Neladenoson Bialanate 20 mg
0.13
± 8.74
Neladenoson Bialanate 30 mg
-2.45
± 10.54
Neladenoson Bialanate 40 mg
1.53
± 10.01
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20Primary· Baseline, Week 20
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
Group
Value
95% CI
Placebo
-0.07
± 0.70
Neladenoson Bialanate 5 mg
-0.24
± 0.90
Neladenoson Bialanate 10 mg
-0.07
± 0.52
Neladenoson Bialanate 20 mg
-0.07
± 0.56
Neladenoson Bialanate 30 mg
0.07
± 0.55
Neladenoson Bialanate 40 mg
-0.08
± 0.79
Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20Secondary· 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.
Group
Value
95% CI
Placebo
-5.44
± 33.29
Neladenoson Bialanate 5 mg
-21.41
± 48.13
Neladenoson Bialanate 10 mg
-2.82
± 35.12
Neladenoson Bialanate 20 mg
-4.32
± 29.73
Neladenoson Bialanate 30 mg
-3.12
± 33.96
Neladenoson Bialanate 40 mg
-15.16
± 39.65
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20Secondary· 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.
Group
Value
95% CI
Placebo
-13.16
± 40.23
Neladenoson Bialanate 5 mg
-21.65
± 61.96
Neladenoson Bialanate 10 mg
-12.44
± 39.84
Neladenoson Bialanate 20 mg
-5.92
± 30.89
Neladenoson Bialanate 30 mg
-11.17
± 42.32
Neladenoson Bialanate 40 mg
-19.69
± 48.38
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20Secondary· Baseline, Week 20
High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
Group
Value
95% CI
Placebo
0.13
± 9.98
Neladenoson Bialanate 5 mg
6.46
± 33.04
Neladenoson Bialanate 10 mg
3.77
± 22.32
Neladenoson Bialanate 20 mg
7.43
± 37.79
Neladenoson Bialanate 30 mg
2.59
± 12.90
Neladenoson Bialanate 40 mg
7.03
± 24.81
Number of Participants With Composite Efficacy OutcomeSecondary· 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.
Group
Value
95% CI
Placebo
10
Neladenoson Bialanate 5 mg
4
Neladenoson Bialanate 10 mg
10
Neladenoson Bialanate 20 mg
9
Neladenoson Bialanate 30 mg
7
Neladenoson Bialanate 40 mg
8
Number of Participants With Cardiovascular (CV) MortalitySecondary· Baseline up to Week 26
Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
Group
Value
95% CI
Placebo
1
Neladenoson Bialanate 5 mg
1
Neladenoson Bialanate 10 mg
3
Neladenoson Bialanate 20 mg
1
Neladenoson Bialanate 30 mg
2
Neladenoson Bialanate 40 mg
1
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)Secondary· Baseline up to Week 26
Number of participants with HF hospitalization and urgent visits for HF were reported.
Group
Value
95% CI
Placebo
10
Neladenoson Bialanate 5 mg
4
Neladenoson Bialanate 10 mg
9
Neladenoson Bialanate 20 mg
8
Neladenoson Bialanate 30 mg
5
Neladenoson Bialanate 40 mg
8
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study drug administration up to 26 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 23 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02992288.