check_circleStudy Completed

Heart Failure

Bayer Identifier:

15128

ClinicalTrials.gov Identifier:

NCT02992288

EudraCT Number:

2016-003839-38

EU CT Number:

Not Available
A trial to study neladenoson bialanate over 20 weeks in patients with chronic heart failure with reduced ejection fraction

Trial purpose

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).

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
427
Trial Dates
February 2017 - May 2018
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Neladenoson Bialanate (BAY1067197)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
CHU de LiègeLIEGE, 4000, Belgium
Withdrawn
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
AZ St-Jan Brugge Oostende AVBRUGGE, 8000, Belgium
Completed
AZ DeltaROESELARE, 8800, Belgium
Completed
Grand Hôpital de CharleroiGILLY, 6060, Belgium
Completed
UMHAT Tsaritsa Joanna-ISUL EAD SofiaSofia, 1527, Bulgaria
Completed
NMTH Tzar Boris IIISofia, 1233, Bulgaria
Completed
MHAT Dr Stefan CherkezovVeliko Tarnovo, 5000, Bulgaria
Completed
AZ TurnhoutTURNHOUT, 2300, Belgium
Completed
Specialized Hospital for Actrive Treatm of Card - PlevenPleven, 5800, Bulgaria
Completed
Spec Hosp for Active Treatm in Cardiology Sv Georgi PernikPernik, 2300, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Sveta SofiaSofia, 1618, Bulgaria
Withdrawn
Imeldaziekenhuis - St-ElisabethkliniekBONHEIDEN, 2820, Belgium
Completed
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)Bad Oeynhausen, 32545, Germany
Completed
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Completed
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
St.-Johannes-Hospital DortmundDortmund, 44137, Germany
Withdrawn
Studienzentrum Dr. AppelKassel, 34128, Germany
Completed
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen, 67063, Germany
Withdrawn
University General Hospital of Athens "ATTIKON"Chaidari - Athens, 12462, Greece
Completed
G. Gennimatas General State Hospital of AthensAthens, 11527, Greece
Completed
Konstantopoulio General Hospital of Nea Ionia - Agia OlgaNea Ionia / Athens, 142 33, Greece
Completed
KAT General Hospital of AthensKifisia / Athens, 14561, Greece
Withdrawn
General Hosp of Athens "Korgialenio-Benakeio" RCHAmpelokipi - Athens, 11526, Greece
Completed
Hippokration General Hospital of ThessalonikiThessaloniki, 54642, Greece
Completed
Thriassio General Hospital of ElefsinaElefsina, 19018, Greece
Completed
East Texas CardiologyHouston, 77002, United States
Completed
Tennessee Center for Clinical TrialsTullahoma, 37388, United States
Completed
Henry Ford Health SystemDetroit, 48202, United States
Completed
Glacier View Research Institute-CardiologyKalispell, 59901, United States
Withdrawn
University of Iowa Hospitals & ClinicsIowa City, 52242, United States
Withdrawn
Holy Cross HospitalFt. Lauderdale, 33308, United States
Completed
University of Mississippi Medical CenterJackson, 39216, United States
Completed
St. Louis Heart & Vascular, PCSt. Louis, 63136, United States
Completed
Stony Brook University Medical CenterStony Brook, 11794, United States
Completed
Assaf Harofeh Medical CenterZrifin, 6093000, Israel
Completed
Barzilai Medical CenterAshkelon, 7830604, Israel
Completed
Shaare Zedek Medical CenterJerusalem, 9103102, Israel
Completed
Hillel Yaffe Medical CenterHadera, 3810101, Israel
Completed
Hadassah University Hospital Mount ScopusJerusalem, Israel
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Completed
ASST Papa Giovanni XXIIIBergamo, 24127, Italy
Completed
ASST Spedali Civili di BresciaBrescia, 25123, Italy
Completed
IRCCS Centro Cardiologico Fondazione MonzinoMilano, 20138, Italy
Completed
AUSL 8 ArezzoArezzo, 52040, Italy
Completed
A.O.U. Policlinico Federico II NapoliNapoli, 80131, Italy
Withdrawn
A.O. San Camillo-ForlaniniRoma, 00151, Italy
Withdrawn
109 Szpital Wojskowy z przychodnia SPZOZSzczecin, 70-965, Poland
Completed
Hospital Universitario "Virgen de la Arrixaca"El Palmar, 30120, Spain
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital General Universitario Gregorio MarañónMadrid, 28007, Spain
Completed
Universitair Medisch Centrum GroningenGRONINGEN, 9700 RB, Netherlands
Withdrawn
Academisch Medisch Centrum (AMC)AMSTERDAM, 1105 AZ, Netherlands
Completed
Erasmus Medisch CentrumROTTERDAM, 3015 CE, Netherlands
Completed
Onze Lieve Vrouwe GasthuisAMSTERDAM, 1091 AC, Netherlands
Completed
NZOZ SALUSLodz, 91-302, Poland
Completed
KLIMED Marek KlimkiewiczBialystok, 15-776, Poland
Completed
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZWroclaw, 50-981, Poland
Completed
Szpital Specjalistyczny im. J. DietlaKrakow, 31-121, Poland
Completed
Hospital Universitari i Politècnic La FeValencia, 46026, Spain
Completed
Szpital Kliniczny Przemienienia PanskiegoPoznan, 61-848, Poland
Completed
Twoja Przychodnia - Szczecinskie Centrum MedyczneSzczecin, 71-434, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-139, Poland
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Complejo Hospitalario Universitario A CoruñaA Coruña, 15006, Spain
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Southwest Florida ResearchNaples, 34102, United States
Completed
Takatsuki Red Cross HospitalTakatsuki, 569-1096, Japan
Completed
Fondazione Policlinico Universitario Agostino GemelliRoma, 00168, Italy
Completed
Toyama Prefectural Central HospitalToyama, 930-8550, Japan
Completed
R.I.A.C Naha City HospitalNaha, 902-8511, Japan
Completed
Kishiwada Tokushukai HospitalKishiwada, 596-8522, Japan
Completed
Ziekenhuis RijnstateARNHEM, 6815 AD, Netherlands
Completed
St. Elizabeth Youngstown HospitalYoungstown, 44501, United States
Completed
Hyogo Prefectural Amagasaki General Medical CenterAmagasaki, 660-8550, Japan
Completed
Tokyo Women's Medical University HospitalShinjuku-ku, 162-8666, Japan
Completed
Nihon University Itabashi HospitalItabashi-ku, 173-8610, Japan
Completed
National hospital Organization Mito Medical CenterHigashiibaraki, 311-3193, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Minamino Cardiovascular HospitalHachioji, 192-0918, Japan
Withdrawn
Aurora Saint Luke's Medical CenterMilwaukee, 53215, United States
Completed
Tel-Aviv Sourasky Medical CenterTel Aviv, 6423906, Israel
Withdrawn
JCHO Kyushu HospitalKitakyushu, 806-8501, Japan
Completed
Okayama Rosai HospitalOkayama, 702-8055, Japan
Withdrawn
Osaka Medical College HospitalTakatsuki, 569-8686, Japan
Completed
Gunma University HospitalMaebashi, 371-8511, Japan
Completed
Hiroshima University HospitalHiroshima, 734-8511, Japan
Withdrawn
Tokyo Heart CenterShinagawa-ku, 141-0001, Japan
Completed
National Hospital Organization Takasaki General Medical CTakasaki, 370-0829, Japan

Primary Outcome

  • Absolute change from baseline in LVEF (%) after 20 weeks
    LVEF: left ventricular ejection fraction
    date_rangeTime Frame:
    At 20 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Absolute change from baseline in log-transformed NT-proBNP (pg/mL) after 20 weeks
    NT-proBNP: N-terminal pro-hormone b-type natriuretic peptide
    date_rangeTime Frame:
    At 20 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Left ventricular end-systolic volume (LVESV; mL)
    Key echocardiographic parameter, measured values and absolute change from baseline at 20 weeks.
    date_rangeTime Frame:
    At 20 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Left ventricular end-diastolic volume (LVEDV; mL)
    Key echocardiographic parameter, measured values and absolute change from baseline at 20 weeks.
    date_rangeTime Frame:
    At 20 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • hs-TNT (ng/L), measured values (log transformed) and absolute / relative change from baseline at 20 weeks as a biomarker of myocardial injury
    hs-TNT: High sensitivity troponin T
    date_rangeTime Frame:
    At 20 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Clinical outcomes
    Clinical outcomes measured by cardiovascular (CV) mortality, heart failure (HF) hospitalization and urgent visits for HF.
    date_rangeTime Frame:
    At 20 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.