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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992288
Recruitment Status : Completed
First Posted : December 14, 2016
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Neladenoson bialanate (BAY1067197) Drug: Placebo Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Statistical Analysis Plan  [PDF] May 29, 2018
Study Protocol  [PDF] February 17, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Chronic Heart Failure
Heart Failure with Reduced Ejection Fraction
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases