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Trial record 2 of 2 for:    neladenoson bialanate | Cardiac Failure | Italy

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
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE December 14, 2016
Results First Submitted Date  ICMJE March 11, 2019
Results First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE February 22, 2017
Actual Primary Completion Date March 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • Absolute change from baseline in left ventricular ejection fraction (LVEF; %) after 20 weeks [ Time Frame: At 20 weeks of treatment ]
  • Absolute change from baseline in log-transformed NT-proBNP (N-terminal pro-hormone b-type natriuretic peptide ) (pg/mL) after 20 weeks [ Time Frame: At 20 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • Left ventricular end-systolic volume (LVESV; mL) [ Time Frame: At 20 weeks of treatment ]
    Key echocardiographic parameter, measured values and absolute change from baseline at 20 weeks.
  • Left ventricular end-diastolic volume (LVEDV; mL) [ Time Frame: At 20 weeks of treatment ]
    Key echocardiographic parameter, measured values and absolute change from baseline at 20 weeks.
  • High sensitivity troponin T (hs-TNT; ng/L), measured values (log transformed) and absolute / relative change from baseline at 20 weeks as a biomarker of myocardial injury [ Time Frame: At 20 weeks of treatment ]
  • Clinical outcomes [ Time Frame: At 20 weeks of treatment ]
    Clinical outcomes measured by cardiovascular (CV) mortality, heart failure (HF) hospitalization and urgent visits for HF.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Neladenoson bialanate (BAY1067197)
    5 mg orally once daily for 20 weeks
  • Drug: Neladenoson bialanate (BAY1067197)
    10 mg orally once daily for 20 weeks
  • Drug: Neladenoson bialanate (BAY1067197)
    20 mg orally once daily for 20 weeks
  • Drug: Neladenoson bialanate (BAY1067197)
    30 mg orally once daily for 20 weeks
  • Drug: Neladenoson bialanate (BAY1067197)
    40 mg orally once daily for 20 weeks
  • Drug: Placebo
    Orally once daily for 20 weeks
Study Arms  ICMJE
  • Experimental: Neladenoson bialanate (BAY1067197) (5 mg)
    Chronic heart failure with reduced ejection fraction
    Intervention: Drug: Neladenoson bialanate (BAY1067197)
  • Experimental: Neladenoson bialanate (BAY1067197) (10 mg)
    Chronic heart failure with reduced ejection fraction
    Intervention: Drug: Neladenoson bialanate (BAY1067197)
  • Experimental: Neladenoson bialanate (BAY1067197) (20 mg)
    Chronic heart failure with reduced ejection fraction
    Intervention: Drug: Neladenoson bialanate (BAY1067197)
  • Experimental: Neladenoson bialanate (BAY1067197) (30 mg)
    Chronic heart failure with reduced ejection fraction
    Intervention: Drug: Neladenoson bialanate (BAY1067197)
  • Experimental: Neladenoson bialanate (BAY1067197) (40 mg)
    Chronic heart failure with reduced ejection fraction
    Intervention: Drug: Neladenoson bialanate (BAY1067197)
  • Placebo Comparator: Placebo
    Chronic heart failure with reduced ejection fraction
    Intervention: Drug: Placebo
Publications * Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, Butler J; PANTHEON Investigators. Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2019 Nov;21(11):1426-1433. doi: 10.1002/ejhf.1591. Epub 2019 Sep 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2017)
427
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
384
Actual Study Completion Date  ICMJE May 16, 2018
Actual Primary Completion Date March 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Belgium,   Bulgaria,   Germany,   Greece,   Israel,   Japan,   Netherlands,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02992288
Other Study ID Numbers  ICMJE 15128
2016-003839-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP