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Heart FailurePhase 2PANTHEONNCT02992288

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

A Phase 2 study testing Neladenoson bialanate (BAY1067197) in people with Heart Failure, run by Bayer at 75 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Neladenoson bialanate (BAY1067197)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
427 participants
Where
75 sitesin 11 countries
Study dates
22 Feb 2017to 16 May 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

75 sites in 11 countries.

75 sites in 11 countries

Japan14 sites

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyōgo, 660-8550

  • Minamino Cardiovascular Hospital

    Hachiōji, Tokyo, 192-0918

  • National hospital Organization Mito Medical Center

    Higashiibaraki, Ibaraki, 311-3193

  • Hiroshima University Hospital

    Hiroshima, 734-8511

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, 596-8522

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • R.I.A.C Naha City Hospital

    Naha, Okinawa, 902-8511

  • Okayama Rosai Hospital

    Okayama, 702-8055

  • Osaka General Medical Center

    Osaka, 558-8558

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • National Hospital Organization Takasaki General Medical C

    Takasaki, Gunma, 370-0829

  • Takatsuki Red Cross Hospital

    Takatsuki, Osaka, 569-1096

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550

Other trials in Japan

United States9 sites

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • East Texas Cardiology

    Houston, Texas, 77002

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Glacier View Research Institute-Cardiology

    Kalispell, Montana, 59901

  • Southwest Florida Research

    Naples, Florida, 34102

  • St. Louis Heart & Vascular, PC

    St Louis, Missouri, 63136

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388

  • St. Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Israel7 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Rambam Health Corporation

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital Mount Scopus

    Jerusalem

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Harofeh Medical Center

    Zrifin, 6093000

Other trials in Israel

Poland7 sites

  • KLIMED Marek Klimkiewicz

    Bialystok, 15-776

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156

  • Szpital Specjalistyczny im. J. Dietla

    Krakow, 31-121

  • Nzoz Salus

    Lodz, 91-302

  • Szpital Kliniczny Przemienienia Panskiego

    Poznan, 61-848

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

    Wroclaw, 50-981

Other trials in Poland

Spain7 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario "Virgen de la Arrixaca"

    El Palmar, Murcia, 30120

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

Bulgaria6 sites

  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

    Pernik, 2300

  • Specialized Hospital for Actrive Treatm of Card - Pleven

    Pleven, 5800

  • NMTH Tzar Boris III

    Sofia, 1233

  • UMHAT Tsaritsa Joanna-ISUL EAD Sofia

    Sofia, 1527

  • Multiprofile Hospital for Active Treatment Sveta Sofia

    Sofia, 1618

  • MHAT Dr Stefan Cherkezov

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Germany6 sites

  • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Charité Campus Virchow-Klinikum (CVK)

    Berlin, 13353

  • St.-Johannes-Hospital Dortmund

    Dortmund, North Rhine-Westphalia, 44137

  • Medizinische Hochschule Hannover (MHH)

    Hanover, Lower Saxony, 30625

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, North Rhine-Westphalia, 41063

Other trials in Germany

Italy6 sites

  • AUSL 8 Arezzo

    Arezzo, Tuscany, 52040

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • IRCCS Centro Cardiologico Fondazione Monzino

    Milan, Lombardy, 20138

  • A.O.U. Policlinico Federico II Napoli

    Naples, Campania, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

Greece5 sites

  • G. Gennimatas General State Hospital of Athens

    Athens, 11527

  • Thriassio General Hospital of Elefsina

    Elefsina, 19018

  • KAT General Hospital of Athens

    Kifisia / Athens, Attica, 14561

  • Konstantopoulio General Hospital of Nea Ionia - Agia Olga

    Nea Ionia / Athens, 142 33

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Belgium4 sites

  • AZ St-Jan Brugge Oostende AV

    Bruges, 8000

  • Grand Hôpital de Charleroi

    Gilly, 6060

  • AZ Delta

    Roeselare, 8800

  • AZ Turnhout

    Turnhout, 2300

Other trials in Belgium

Netherlands4 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

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

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).

Conditions
Heart Failure
Being tested
Neladenoson bialanate (BAY1067197), Placebo
Keywords
Chronic Heart Failure, Heart Failure with Reduced Ejection Fraction
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neladenoson bialanate (BAY1067197)Drug

    5 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    10 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    20 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    30 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    40 mg orally once daily for 20 weeks

  • PlaceboDrug

    Orally once daily for 20 weeks

Study groups in NCT02992288
Study groupRoleWhat they receive
Neladenoson bialanate (BAY1067197) (5 mg)ExperimentalChronic heart failure with reduced ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (10 mg)ExperimentalChronic heart failure with reduced ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (20 mg)ExperimentalChronic heart failure with reduced ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (30 mg)ExperimentalChronic heart failure with reduced ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (40 mg)ExperimentalChronic heart failure with reduced ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
PlaceboPlacebo comparatorChronic heart failure with reduced ejection fraction
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography

    Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.

    Measured: Baseline, Week 20

  2. Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20

    NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.

    Measured: Baseline, Week 20

Secondary outcomes (6)

  1. Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at 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.

    Measured: Baseline, Week 20

  2. Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at 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.

    Measured: Baseline, Week 20

  3. Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20

    High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.

    Measured: Baseline, Week 20

  4. Number of Participants With Composite Efficacy Outcome

    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.

    Measured: Baseline up to Week 26

  5. Number of Participants With Cardiovascular (CV) Mortality

    Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.

    Measured: Baseline up to Week 26

  6. Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)

    Number of participants with HF hospitalization and urgent visits for HF were reported.

    Measured: Baseline up to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2016 (estimated)
  2. Study start22 Feb 2017
  3. Primary completion28 Mar 2018
  4. Study completion16 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02992288
Sponsor's protocol ID
15128
Other IDs
2016-003839-38, 2016
Acronym
PANTHEON
Status last verified
Apr 2019
First submitted
12 Dec 2016
Last updated
23 Apr 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 31523892

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neladenoson bialanate (BAY1067197) in people with Heart Failure, run by Bayer at 75 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Japan, United States, Israel, Poland, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography (time frame: Baseline, Week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02992288, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.

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