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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

427

Phase

  • 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 Maranon
      • Madrid, Spain, 28040
        • Hospital Clínico Universitario San Carlos
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clinico 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

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
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
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

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

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

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)

February 22, 2017

Primary Completion (ACTUAL)

March 28, 2018

Study Completion (ACTUAL)

May 16, 2018

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Heart Failure

Clinical Trials on Neladenoson bialanate (BAY1067197)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe