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

Last updated: July 4, 2019
Sponsor: Bayer
Overall Status: Completed

Phase

2

Condition

Heart Failure

Congestive Heart Failure

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT03098979
17582
2016-004062-26
  • Ages > 45
  • All Genders

Study Summary

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women aged 45 years and older

  • Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV,LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP

Exclusion

Exclusion Criteria:

  • Acute decompensated heart failure within the past 4 weeks

  • Inability to exercise

  • Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)

Study Design

Total Participants: 305
Study Start date:
May 10, 2017
Estimated Completion Date:
June 20, 2018

Connect with a study center

  • Universitätsklinikum St. Pölten

    St. Pölten, Niederösterreich 3100
    Austria

    Site Not Available

  • Krankenhaus St. Josef Braunau

    Braunau, Oberösterreich 5280
    Austria

    Site Not Available

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, Oberösterreich 4020
    Austria

    Site Not Available

  • Medizinische Universität Graz

    Graz, Steiermark 8036
    Austria

    Site Not Available

  • Vorarlberg Institute for Vascular Investigation & Treatment

    Feldkirch, Vorarlberg 6807
    Austria

    Site Not Available

  • Allgemeines Krankenhaus der Stadt Wien

    Wien, 1090
    Austria

    Site Not Available

  • Krankenhaus Hietzing

    Wien, 1130
    Austria

    Site Not Available

  • empty

    Brugge, 8000
    Belgium

    Site Not Available

  • Hôpital Erasme/Erasmus Ziekenhuis

    Bruxelles - Brussel, 1070
    Belgium

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • CHR de la Citadelle

    Liege, 4000
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

    Pernik, 2300
    Bulgaria

    Site Not Available

  • Specialized Hospital for Actrive Treatm of Card - Pleven

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Medical Center Cardiohelp

    Sofia, 1142
    Bulgaria

    Site Not Available

  • NMTH Tzar Boris III

    Sofia, 1233
    Bulgaria

    Site Not Available

  • UMHAT Tsaritsa Joanna-ISUL EAD Sofia

    Sofia, 1527
    Bulgaria

    Site Not Available

  • MCOMH Preventsia-2000

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Deutsches Herzzentrum München

    München, Bayern 80636
    Germany

    Site Not Available

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

    Bad Oeynhausen, Nordrhein-Westfalen 32545
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, Nordrhein-Westfalen 41063
    Germany

    Site Not Available

  • St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH

    Dresden, Sachsen 01069
    Germany

    Site Not Available

  • HELIOS Klinikum Erfurt GmbH

    Erfurt, Thüringen 99089
    Germany

    Site Not Available

  • Charité Campus Virchow-Klinikum (CVK)

    Berlin, 13353
    Germany

    Site Not Available

  • KAT General Hospital of Athens

    Kifisia, Attica 14561
    Greece

    Site Not Available

  • KAT General Hospital of Athens

    Kifisia / Athens, Attica 14561
    Greece

    Site Not Available

  • General Hosp of Athens "Korgialenio-Benakeio" RCH

    Abelokipi - Athens, 115 26
    Greece

    Site Not Available

  • General Hosp of Athens "Korgialenio-Benakeio" RCH

    Ampelokipi - Athens, 11526
    Greece

    Site Not Available

  • G. Gennimatas General State Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • General Hospital of Chalkida

    Chalkida, 34100
    Greece

    Site Not Available

  • University General Hospital of Athens "ATTIKON"

    Haidari, 12462
    Greece

    Site Not Available

  • University General Hospital of Athens "ATTIKON"

    Haidari - Athens, 12462
    Greece

    Site Not Available

  • Konstantopoulio General Hospital of Nea Ionia - Agia Olga

    Nea Ionia, 14233
    Greece

    Site Not Available

  • Konstantopoulio General Hospital of Nea Ionia - Agia Olga

    Nea Ionia / Athens, 142 33
    Greece

    Site Not Available

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, 54642
    Greece

    Site Not Available

  • Asklipieion General Hospital of Voulas

    Voula, 16673
    Greece

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 7830604
    Israel

    Site Not Available

  • Hillel Yaffe Medical Center

    Hadera, 3810101
    Israel

    Site Not Available

  • Rambam Health Corporation

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah University Hospital Mount Scopus

    Jerusalem,
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • empty

    Rehovot, 7610001
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Zrifin, 6093000
    Israel

    Site Not Available

  • AAS 3 Friuli Alto Medio Collin

    Udine, Friuli-Venezia Giulia 33038
    Italy

    Site Not Available

  • A.O.U. Sant'Andrea

    Roma, Lazio 00189
    Italy

    Site Not Available

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardia 24127
    Italy

    Site Not Available

  • ASST Spedali Civili di Brescia

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • A.O. Ordine Mauriziano

    Torino, Piemonte 10128
    Italy

    Site Not Available

  • A.O.U. di Sassari

    Sassari, Sardegna 07100
    Italy

    Site Not Available

  • AUSL Toscana Sud-Est

    Arezzo, Toscana 52040
    Italy

    Site Not Available

  • empty

    Rovigo, Veneto 45100
    Italy

    Site Not Available

  • Chuno kosei Hospital

    Seki, Gifu 501-3802
    Japan

    Site Not Available

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyogo 660-8550
    Japan

    Site Not Available

  • National hospital Organization Mito Medical Center

    Higashiibaraki, Ibaraki 311-3193
    Japan

    Site Not Available

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa 920-8650
    Japan

    Site Not Available

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa, Kanagawa 251-0041
    Japan

    Site Not Available

  • R.I.A.C Naha City Hospital

    Naha, Okinawa 902-8511
    Japan

    Site Not Available

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka 596-8522
    Japan

    Site Not Available

  • Osaka Medical College Hospital

    Takatsuki, Osaka 569-8686
    Japan

    Site Not Available

  • Takatsuki Red Cross Hospital

    Takatsuki, Osaka 569-1096
    Japan

    Site Not Available

  • Chutoen General Medical Center

    Kakegawa, Shizuoka 436-8555
    Japan

    Site Not Available

  • Minamino Cardiovascular Hospital

    Hachioji, Tokyo 192-0918
    Japan

    Site Not Available

  • Tokyo Heart Center

    Shinagawa-ku, Tokyo 141-0001
    Japan

    Site Not Available

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo 162-8666
    Japan

    Site Not Available

  • Sanin Rosai Hospital

    Yonago, Tottori 683-8605
    Japan

    Site Not Available

  • Fukui Prefectural Hospital

    Fukui, 910-8526
    Japan

    Site Not Available

  • Okayama Rosai Hospital

    Okayama, 702-8055
    Japan

    Site Not Available

  • Osaka General Medical Center

    Osaka, 558-8558
    Japan

    Site Not Available

  • Tokushima Prefectural Central Hospital

    Tokushima, 770-8539
    Japan

    Site Not Available

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550
    Japan

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276
    Poland

    Site Not Available

  • Szpital Zachodni w Grodzisku Mazowieckim

    Grodzisk Mazowiecki, 05-825
    Poland

    Site Not Available

  • Szpital Specjalistyczny im. J. Dietla

    Krakow, 31-121
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego

    Lodz, 91-347
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Olsztynie

    Olsztyn, 10-082
    Poland

    Site Not Available

  • 109 Szpital Wojskowy z przychodnia SPZOZ

    Szczecin, 70-965
    Poland

    Site Not Available

  • Szpital Wolski im. dr Anny Gostynskiej SPZOZ

    Warszawa, 02-211
    Poland

    Site Not Available

  • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

    Wroclaw, 50-981
    Poland

    Site Not Available

  • CHUC - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • CHLO - Hospital São Francisco Xavier

    Lisboa, 1449-005
    Portugal

    Site Not Available

  • Hospital da Luz

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • CHUP, EPE - Hospital de Santo Antonio

    Porto, 4099-001
    Portugal

    Site Not Available

  • Hospital Sanitas La Zarzuela

    Aravaca, Madrid 28023
    Spain

    Site Not Available

  • Hospital Universitario "Virgen de la Arrixaca"

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • empty

    La Jolla, California 92037
    United States

    Site Not Available

  • Holy Cross Hospital

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Holy Cross Hospital

    Ft. Lauderdale, Florida 33308
    United States

    Site Not Available

  • University of Florida - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • empty

    New Orleans, Louisiana 70112-1396
    United States

    Site Not Available

  • Anne Arundel Health System

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • empty

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • St. Louis Heart & Vascular, PC

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • BryanLGH Medical Center East

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157-1045
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • empty

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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