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

April 19, 2019 updated by: Bayer

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
427

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ St-Jan Brugge Oostende AV
      • Gilly, Belgium, 6060
        • Grand Hôpital de Charleroi
      • Roeselare, Belgium, 8800
        • AZ Delta
      • Turnhout, Belgium, 2300
        • AZ Turnhout
  • Bulgaria
      • Pernik, Bulgaria, 2300
        • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
      • Pleven, Bulgaria, 5800
        • Specialized Hospital for Actrive Treatm of Card - Pleven
      • Sofia, Bulgaria, 1233
        • NMTH Tzar Boris III
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Joanna-ISUL EAD Sofia
      • Sofia, Bulgaria, 1618
        • Multiprofile Hospital for Active Treatment Sveta Sofia
      • Veliko Tarnovo, Bulgaria, 5000
        • MHAT Dr Stefan Cherkezov
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum (CVK)
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover (MHH)
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
        • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
        • St.-Johannes-Hospital Dortmund
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
        • Kliniken Maria Hilf GmbH
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Greece
      • Athens, Greece, 11527
        • G. GENNIMATAS General State Hospital of Athens
      • Elefsina, Greece, 19018
        • Thriassio General Hospital of Elefsina
      • Nea Ionia / Athens, Greece, 142 33
        • Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
      • Thessaloniki, Greece, 54642
        • Hippokration General Hospital of Thessaloniki
    • Attica
      • Kifisia / Athens, Attica, Greece, 14561
        • KAT General Hospital of Athens
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Hadera, Israel, 3810101
        • Hillel Yaffe Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Corporation
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel
        • Hadassah University Hospital Mount Scopus
      • Tel Aviv, Israel, 6423906
        • Tel-Aviv Sourasky Medical Center
      • Zrifin, Israel, 6093000
        • Assaf Harofeh Medical Center
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • A.O.U. Policlinico Federico II Napoli
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Asst Papa Giovanni Xxiii
      • Brescia, Lombardia, Italy, 25123
        • ASST Spedali Civili di Brescia
      • Milano, Lombardia, Italy, 20138
        • IRCCS Centro Cardiologico Fondazione Monzino
    • Toscana
      • Arezzo, Toscana, Italy, 52040
        • AUSL 8 Arezzo
  • Japan
      • Hiroshima, Japan, 734-8511
        • Hiroshima University Hospital
      • Okayama, Japan, 702-8055
        • Okayama Rosai Hospital
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical C
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 311-3193
        • National Hospital Organization Mito Medical Center
    • Okinawa
      • Naha, Okinawa, Japan, 902-8511
        • R.I.A.C Naha City Hospital
    • Osaka
      • Kishiwada, Osaka, Japan, 596-8522
        • Kishiwada Tokushukai Hospital
      • Takatsuki, Osaka, Japan, 569-1096
        • Takatsuki Red Cross Hospital
    • Tokyo
      • Hachioji, Tokyo, Japan, 192-0918
        • Minamino Cardiovascular Hospital
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
      • Arnhem, Netherlands, 6815 AD
        • Ziekenhuis Rijnstate
      • Groningen, Netherlands, 9700 RB
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medisch Centrum
  • Poland
      • Bialystok, Poland, 15-776
        • KLIMED Marek Klimkiewicz
      • Katowice, Poland, 40-156
        • CLINICAL MEDICAL RESEARCH Sp. z o. o.
      • Krakow, Poland, 31-121
        • Szpital Specjalistyczny im. J. Dietla
      • Lodz, Poland, 91-302
        • Nzoz Salus
      • Poznan, Poland, 61-848
        • Szpital Kliniczny Przemienienia Pańskiego
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Wroclaw, Poland, 50-981
        • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario "Virgen de la Arrixaca"
  • United States
    • Florida
      • Naples, Florida, United States, 34102
        • Southwest Florida Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • St. Louis Heart & Vascular, PC
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Research Institute-Cardiology
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • Ohio
      • Youngstown, Ohio, United States, 44501
        • St. Elizabeth Youngstown Hospital
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Tennessee Center for Clinical Trials
    • Texas
      • Houston, Texas, United States, 77002
        • East Texas Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
EXPERIMENTAL: Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with reduced ejection fraction
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
EXPERIMENTAL: Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with reduced ejection fraction
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
EXPERIMENTAL: Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with reduced ejection fraction
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
EXPERIMENTAL: Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with reduced ejection fraction
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
PLACEBO_COMPARATOR: Placebo
Chronic heart failure with reduced ejection fraction
Drug: Placebo
Orally once daily for 20 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 20
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.
Baseline, Week 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 20
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.
Baseline, Week 20
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.
Baseline, Week 20
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.
Baseline up to Week 26
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.
Baseline up to Week 26
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.
Baseline up to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15128
  • 2016-003839-38 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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