Phase 2 N=427 Randomized Quadruple-blind Treatment

A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02992288 ↗

Enrolled (actual)

427

Serious AEs

34.7%

Results posted

Apr 2019

Primary outcome: Primary: Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography — -2.19; 2.59; -3.01; 0.13 Percentage of LVEF — p=0.2297

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Neladenoson bialanate (BAY1067197) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography	-2.19; 2.59; -3.01; 0.13; -2.45; 1.53	0.2297
PRIMARY Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20	-0.07; -0.24; -0.07; -0.07; 0.07; -0.08	0.8966
SECONDARY Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20	-5.44; -21.41; -2.82; -4.32; -3.12; -15.16	0.4596
SECONDARY Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20	-13.16; -21.65; -12.44; -5.92; -11.17; -19.69	0.5703
SECONDARY Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20	0.13; 6.46; 3.77; 7.43; 2.59; 7.03	0.9955
SECONDARY Number of Participants With Composite Efficacy Outcome	10; 4; 10; 9; 7; 8	—
SECONDARY Number of Participants With Cardiovascular (CV) Mortality	1; 1; 3; 1; 2; 1	—
SECONDARY Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)	10; 4; 9; 8; 5; 8	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02992288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.