Study Completed

Heart Failure

Bayer Identifier:

17582

ClinicalTrials.gov Identifier:

NCT03098979

EudraCT Number:

2016-004062-26

EU CT Number:

Not Available

A trial to study neladenoson bialanate over 20 weeks in patients with chronic heart failure with preserved ejection fraction

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

45 - N/A

Trial summary

Enrollment Goal

305

Trial Dates

May 2017 - June 2018

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Neladenoson Bialanate (BAY1067197)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	UMHAT Tsaritsa Joanna-ISUL EAD Sofia	Sofia, 1527, Bulgaria
Completed	NMTH Tzar Boris III	Sofia, 1233, Bulgaria
Completed	MCOMH Preventsia-2000	Stara Zagora, 6000, Bulgaria
Completed	Specialized Hospital for Actrive Treatm of Card - Pleven	Pleven, 5800, Bulgaria
Completed	¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OOD	Pernik, 2300, Bulgaria
Completed	Universitätsklinikum AKH Wien	Wien, 1090, Austria
Completed	Medizinische Universität Graz	Graz, 8036, Austria
Withdrawn	Hôpital Erasme/Erasmus Ziekenhuis	BRUXELLES - BRUSSEL, 1070, Belgium
Completed	Jessa Ziekenhuis	HASSELT, 3500, Belgium
Completed	CHR de la Citadelle	Liege, 4000, Belgium
Completed	AZ Delta	ROESELARE, 8800, Belgium
Withdrawn	University General Hospital of Athens "ATTIKON"	Chaidari - Athens, 12462, Greece
Completed	G. GENNIMATAS General State Hospital of Athens	Athens, 11527, Greece
Completed	Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA	Nea Ionia / Athens, 142 33, Greece
Completed	KAT General Hospital of Athens	Kifisia / Athens, 14561, Greece
Withdrawn	General Hosp of Athens "Korgialenio-Benakeio" RCH	Ampelokipi - Athens, 11526, Greece
Completed	Hippokration General Hospital of Thessaloniki	Thessaloniki, 54642, Greece
Completed	Asklipieion General Hospital of Voulas	Voula, 16673, Greece
Withdrawn	University of Iowa Hospitals & Clinics	Iowa City, 52242, United States
Completed	Medical Center Cardiohelp	Sofia, 1142, Bulgaria
Completed	General Hospital of Chalkida	Chalkida, 34100, Greece
Withdrawn	Ohio State University Wexner Medical Center	Columbus, 43210, United States
Completed	Wake Forest Baptist Health	Winston-Salem, 27157-1045, United States
Completed	BryanLGH Medical Center East	Lincoln, 68506, United States
Withdrawn	Henry Ford Health System	Detroit, 48202, United States
Withdrawn	Holy Cross Hospital	Ft. Lauderdale, 33308, United States
Withdrawn	University of Florida - Jacksonville	Jacksonville, 32209, United States
Completed	Northwestern University	Chicago, 60611, United States
Withdrawn	Anne Arundel Health System	Annapolis, 21401, United States
Withdrawn	Aurora Saint Luke's Medical Center	Milwaukee, 53215, United States
Completed	ASST Papa Giovanni XXIII	Bergamo, 24127, Italy
Completed	AUSL Toscana Sud-Est	Arezzo, 52044, Italy
Completed	ASST Spedali Civili di Brescia	Brescia, 25123, Italy
Completed	AAS 3 Friuli Alto Medio Collin	Udine, 33038, Italy
Completed	A.O.U. Sant'Andrea	Roma, 00189, Italy
Completed	A.O.U. di Sassari	Sassari, 07100, Italy
Completed	A.O. Ordine Mauriziano	Torino, 10128, Italy
Completed	Ordensklinikum Linz GmbH Elisabethinen	Linz, 4020, Austria
Completed	Klinik Hietzing	Wien, 1130, Austria
Completed	Shamir Medical Center (Assaf Harofeh)	Zrifin, 7030000, Israel
Completed	Barzilai Medical Center	Ashkelon, 7830604, Israel
Completed	Shaare Zedek Medical Center	Jerusalem, 9103102, Israel
Completed	Hillel Yaffe Medical Center	Hadera, 3810101, Israel
Completed	Hadassah University Hospital Mount Scopus	Jerusalem, Israel
Completed	Rambam Health Corporation	Haifa, 3109601, Israel
Completed	Krankenhaus St. Josef Braunau	Braunau, 5280, Austria
Completed	Hospital da Luz - Lisboa	Lisboa, 1500-650, Portugal
Completed	CHUC - Hospitais da Universidade de Coimbra	Coimbra, 3000-075, Portugal
Completed	CHLO - Hospital Sao Francisco Xavier	Lisboa, 1449-005, Portugal
Completed	109 Szpital Wojskowy z przychodnia SPZOZ	Szczecin, 70-965, Poland
Completed	IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ	Wroclaw, 50-981, Poland
Withdrawn	Uniwersytecki Szpital Kliniczny w Olsztynie	Olsztyn, 10-082, Poland
Completed	Hospital Clínico Universitario de Valencia	Valencia, 46010, Spain
Completed	Hospital Universitari i Politècnic La Fe	Valencia, 46026, Spain
Completed	Hospital Sanitas La Zarzuela	Aravaca, 28023, Spain
Completed	Hospital Clínico Universitario San Carlos	Madrid, 28040, Spain
Completed	Hospital General Universitario Gregorio Marañón	Madrid, 28007, Spain
Completed	Hospital Virgen de la Victoria	Málaga, 29010, Spain
Completed	Hospital Clinico Universitario Virgen de la Arrixaca \| Neurology Department - Stroke	El Palmar, 30120, Spain
Completed	Hospital del Mar	Barcelona, 08003, Spain
Completed	Charité - Campus Virchow-Klinikum (CVK)	Berlin, 13353, Germany
Completed	HELIOS Klinikum Erfurt GmbH	Erfurt, 99089, Germany
Completed	Klinische Forschung Dresden GmbH	Dresden, 01069, Germany
Withdrawn	Isar Herz Zentrum	München, 80331, Germany
Withdrawn	Kliniken Maria Hilf GmbH	Mönchengladbach, 41063, Germany
Completed	Marienhaus Klinikum Mainz	Mainz, 55131, Germany
Completed	Szpital Specjalistyczny im. J. Dietla	Krakow, 31-121, Poland
Completed	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok, 15-276, Poland
Completed	Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego	Lodz, 91-347, Poland
Completed	Szpital Wolski im. dr Anny Gostynskiej SPZOZ	Warszawa, 02-211, Poland
Completed	Samodzielny Publiczny Specjalistyczny Szpital Zachodni	Grodzisk Mazowiecki, 05-825, Poland
Completed	Universitätsklinikum St. Pölten	St. Pölten, 3100, Austria
Completed	Tel-Aviv Sourasky Medical Center	Tel Aviv, 6423906, Israel
Completed	Centro Hospitalar Universitario do Porto	Porto, 4099-001, Portugal
Completed	Takatsuki Red Cross Hospital	Takatsuki, 569-1096, Japan
Withdrawn	Toyama Prefectural Central Hospital	Toyama, 930-8550, Japan
Completed	R.I.A.C Naha City Hospital	Naha, 902-8511, Japan
Completed	Kishiwada Tokushukai Hospital	Kishiwada, 596-0042, Japan
Completed	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki, 660-8550, Japan
Completed	Tokyo Women's Medical University Hospital	Shinjuku-ku, 162-8666, Japan
Completed	Fukui Prefectural Hospital	Fukui, 910-8526, Japan
Withdrawn	Japan Organization of Occupational Health and Safety Sanin Rosai Hospital	Yonago, 683-8605, Japan
Completed	Tokushima Prefectural Central Hospital	Tokushima, 770-8539, Japan
Completed	National Hospital Organization Kanazawa Medical Center	Kanazawa, 920-8650, Japan
Withdrawn	National hospital Organization Mito Medical Center	Higashiibaraki, 311-3193, Japan
Completed	Osaka General Medical Center	Osaka, 558-8558, Japan
Withdrawn	Chutoen General Medical Center	Kakegawa, 436-8555, Japan
Completed	Minamino Cardiovascular Hospital	Hachioji, 192-0918, Japan
Completed	Okayama Rosai Hospital	Okayama, 702-8055, Japan
Completed	Osaka Medical College Hospital	Takatsuki, 569-8686, Japan
Completed	Shonan Fujisawa Tokushukai Hospital	Fujisawa, 251-0041, Japan
Withdrawn	Tokyo Heart Center	Shinagawa-ku, 141-0001, Japan
Completed	St. Louis Heart & Vascular, PC	St. Louis, 63136, United States
Completed	Chuno kosei Hospital	Seki, 501-3802, Japan
Withdrawn	Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)	Bad Oeynhausen, 32545, Germany

Primary Outcome

Absolute change from baseline in 6MWD after 20 weeks of treatment
6MWD: 6-minute walking distance
Time Frame:
At 20 weeks of treatment

Secondary Outcome

Absolute change in activity from baseline to 20 weeks
Activity is an important limitation in patients with preserved heart failure. This endpoint is to measure the in ability to exercise and improvement over 20 weeks.
Time Frame:
At 20 weeks of treatment
NT-proBNP (pg/mL), measured values (log transformed) and absolute / relative change from baseline at 20 weeks to assess elevated filling pressures
NT-proBNP: N-terminal pro-hormone b-type natriuretic peptide
Time Frame:
At 20 weeks of treatment
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
Time Frame:
At 20 weeks of treatment
KCCQ (Kansas City cardiomyopathy questionnaire), measured values and absolute / relative change from baseline
The KCCQ is the leading health-related quality-of-life measure for patients with chronic heart failure (CHF). It is a 23-item questionnaire that independently measures the impact of patients’ heart failure (HF), or its treatment, on 7 distinct domains.
Time Frame:
At 20 weeks of treatment

Trial design

A multicenter, randomized, placebo-controlled, parallel group, double blind, dose-finding Phase II trial to study the efficacy, safety, pharmacokinetics and pharmacodynamic effects of the oral partial adenosine A1 receptor agonist neladenoson bialanate over 20 weeks in patients with chronic heart failure and preserved ejection fraction

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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