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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
427
5 mg orally once daily for 20 weeks
10 mg orally once daily for 20 weeks
20 mg orally once daily for 20 weeks
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
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
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
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
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
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.
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30 mg orally once daily for 20 weeks
40 mg orally once daily for 20 weeks
Orally once daily for 20 weeks
Southwest Florida Research
Naples, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis Heart & Vascular, PC
St Louis, Missouri, United States
Glacier View Research Institute-Cardiology
Kalispell, Montana, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
East Texas Cardiology
Houston, Texas, United States
AZ St-Jan Brugge Oostende AV
Bruges, Belgium
...and 65 more locations
Time frame: Baseline up to Week 26
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
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