A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
NCT ID: NCT03098979
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
305 participants
INTERVENTIONAL
2017-05-10
2018-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neladenoson bialanate (BAY1067197) (5 mg)
Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with preserved ejection fraction
Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks
Placebo
Chronic heart failure with preserved ejection fraction
Placebo
Orally once daily for 20 weeks
Interventions
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Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks
Placebo
Orally once daily for 20 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP
Exclusion Criteria
* Inability to exercise
* Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF \< 40%)
45 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Northwestern University
Chicago, Illinois, United States
St. Louis Heart & Vascular, PC
St Louis, Missouri, United States
BryanLGH Medical Center East
Lincoln, Nebraska, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, Austria
Medizinische Universität Graz
Graz, Styria, Austria
Krankenhaus St. Josef Braunau
Braunau am Inn, Upper Austria, Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz, Upper Austria, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
Krankenhaus Hietzing
Vienna, , Austria
Jessa Ziekenhuis
Hasselt, , Belgium
CHR de la Citadelle
Liège, , Belgium
AZ Delta
Roeselare, , Belgium
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
Pernik, , Bulgaria
Specialized Hospital for Actrive Treatm of Card - Pleven
Pleven, , Bulgaria
Medical Center Cardiohelp
Sofia, , Bulgaria
NMTH Tzar Boris III
Sofia, , Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, , Bulgaria
MCOMH Preventsia-2000
Stara Zagora, , Bulgaria
St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
Mainz, Rhineland-Palatinate, Germany
Klinische Forschung Dresden GmbH
Dresden, Saxony, Germany
HELIOS Klinikum Erfurt GmbH
Erfurt, Thuringia, Germany
Charité Campus Virchow-Klinikum (CVK)
Berlin, , Germany
KAT General Hospital of Athens
Kifisia / Athens, Attica, Greece
G. Gennimatas General State Hospital of Athens
Athens, , Greece
General Hospital of Chalkida
Chalcis, , Greece
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
Nea Ionia / Athens, , Greece
Hippokration General Hospital of Thessaloniki
Thessaloniki, , Greece
Asklipieion General Hospital of Voulas
Voula, , Greece
Barzilai Medical Center
Ashkelon, , Israel
Hillel Yaffe Medical Center
Hadera, , Israel
Rambam Health Corporation
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital Mount Scopus
Jerusalem, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Assaf Harofeh Medical Center
Zrifin, , Israel
AAS 3 Friuli Alto Medio Collin
Udine, Friuli Venezia Giulia, Italy
A.O.U. Sant'Andrea
Rome, Lazio, Italy
ASST Papa Giovanni XXIII
Bergamo, Lombardy, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
A.O. Ordine Mauriziano
Turin, Piedmont, Italy
A.O.U. di Sassari
Sassari, Sardinia, Italy
AUSL Toscana Sud-Est
Arezzo, Tuscany, Italy
Chuno kosei Hospital
Sekimachi, Gifu, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, Japan
R.I.A.C Naha City Hospital
Naha, Okinawa, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Fukui Prefectural Hospital
Fukui, , Japan
Okayama Rosai Hospital
Okayama, , Japan
Osaka General Medical Center
Osaka, , Japan
Tokushima Prefectural Central Hospital
Tokushima, , Japan
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Szpital Zachodni w Grodzisku Mazowieckim
Grodzisk Mazowiecki, , Poland
Szpital Specjalistyczny im. J. Dietla
Krakow, , Poland
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
Lodz, , Poland
109 Szpital Wojskowy z przychodnia SPZOZ
Szczecin, , Poland
Szpital Wolski im. dr Anny Gostynskiej SPZOZ
Warsaw, , Poland
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
Wroclaw, , Poland
CHUC - Hospitais da Universidade de Coimbra
Coimbra, , Portugal
CHLO - Hospital São Francisco Xavier
Lisbon, , Portugal
Hospital da Luz
Lisbon, , Portugal
CHUP, EPE - Hospital de Santo Antonio
Porto, , Portugal
Hospital Sanitas La Zarzuela
Aravaca, Madrid, Spain
Hospital Universitario "Virgen de la Arrixaca"
El Palmar, Murcia, Spain
Hospital del Mar
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Clínico Universitario San Carlos
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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References
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Shah SJ, Voors AA, McMurray JJV, Kitzman DW, Viethen T, Bomfim Wirtz A, Huang E, Pap AF, Solomon SD. Effect of Neladenoson Bialanate on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2101-2112. doi: 10.1001/jama.2019.6717.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2016-004062-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17582
Identifier Type: -
Identifier Source: org_study_id
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