A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction (PANTHEON)
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ClinicalTrials.gov Identifier: NCT02992288 |
Recruitment Status :
Completed
First Posted : December 14, 2016
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Drug: Neladenoson bialanate (BAY1067197) Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 427 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction |
Actual Study Start Date : | February 22, 2017 |
Actual Primary Completion Date : | March 28, 2018 |
Actual Study Completion Date : | May 16, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Neladenoson bialanate (BAY1067197) (5 mg)
Chronic heart failure with reduced ejection fraction
|
Drug: Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks |
Experimental: Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with reduced ejection fraction
|
Drug: Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks |
Experimental: Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with reduced ejection fraction
|
Drug: Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks |
Experimental: Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with reduced ejection fraction
|
Drug: Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks |
Experimental: Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with reduced ejection fraction
|
Drug: Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks |
Placebo Comparator: Placebo
Chronic heart failure with reduced ejection fraction
|
Drug: Placebo
Orally once daily for 20 weeks |
- Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography [ Time Frame: 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 [ Time Frame: Baseline, Week 20 ]NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
- Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 [ Time Frame: 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.
- Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 [ Time Frame: 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.
- Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 [ Time Frame: Baseline, Week 20 ]High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
- Number of Participants With Composite Efficacy Outcome [ Time Frame: 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.
- Number of Participants With Cardiovascular (CV) Mortality [ Time Frame: Baseline up to Week 26 ]Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
- Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) [ Time Frame: Baseline up to Week 26 ]Number of participants with HF hospitalization and urgent visits for HF were reported.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992288

Study Director: | Bayer Study Director | Bayer |
Documents provided by Bayer:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT02992288 |
Other Study ID Numbers: |
15128 2016-003839-38 ( EudraCT Number ) |
First Posted: | December 14, 2016 Key Record Dates |
Results First Posted: | April 23, 2019 |
Last Update Posted: | April 23, 2019 |
Last Verified: | April 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Heart Failure Heart Failure with Reduced Ejection Fraction |
Heart Failure Heart Diseases Cardiovascular Diseases |