Trial Condition(s):
Heart Failure
A trial to study neladenoson bialanate over 20 weeks in patients with chronic heart failure with preserved ejection fraction (PANACHE)
Bayer Identifier:
17582
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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 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%)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia, Bulgaria, 1527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NMTH Tzar Boris III Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MCOMH Preventsia-2000 Stara Zagora, Bulgaria, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Specialized Hospital for Actrive Treatm of Card - Pleven Pleven, Bulgaria, 5800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik Pernik, Bulgaria, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Allgemeines Krankenhaus der Stadt Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected]com Phone: (+) 1-888-8422937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jessa Ziekenhuis HASSELT, Belgium, 3500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHR de la Citadelle LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations G. Gennimatas General State Hospital of Athens Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Konstantopoulio General Hospital of Nea Ionia - Agia Olga Nea Ionia / Athens, Greece, 142 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations KAT General Hospital of Athens Kifisia / Athens, Greece, 14561 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asklipieion General Hospital of Voulas Voula, Greece, 16673 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center Cardiohelp Sofia, Bulgaria, 1142 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations General Hospital of Chalkida Chalkida, Greece, 34100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27157-1045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations BryanLGH Medical Center East Lincoln, United States, 68506 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northwestern University Chicago, United States, 60611 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AUSL Toscana Sud-Est Arezzo, Italy, 52040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AAS 3 Friuli Alto Medio Collin Udine, Italy, 33038 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O. Sant'Andrea Roma, Italy, 00189 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Sassari Sassari, Italy, 07100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O. Ordine Mauriziano Torino, Italy, 10128 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus der Elisabethinen Linz GmbH Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus Hietzing Wien, Austria, 1130 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Assaf Harofeh Medical Center Zrifin, Israel, 6093000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 9103102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hillel Yaffe Medical Center Hadera, Israel, 3810101 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hadassah University Hospital Mount Scopus Jerusalem, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus St. Josef Braunau Braunau, Austria, 5280 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital da Luz Lisboa, Portugal, 1500-650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHUC - Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-075 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHLO - Hospital São Francisco Xavier Lisboa, Portugal, 1449-005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 109 Szpital Wojskowy z przychodnia SPZOZ Szczecin, Poland, 70-965 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ Wroclaw, Poland, 50-981 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Sanitas La Zarzuela Aravaca, Spain, 28023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario "Virgen de la Arrixaca" El Palmar, Spain, 30120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HELIOS Klinikum Erfurt GmbH Erfurt, Germany, 99089 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinische Forschung Dresden GmbH Dresden, Germany, 01069 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Specjalistyczny im. J. Dietla Krakow, Poland, 31-121 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego Lodz, Poland, 91-347 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Wolski im. dr Anny Gostynskiej SPZOZ Warszawa, Poland, 02-211 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Zachodni w Grodzisku Mazowieckim Grodzisk Mazowiecki, Poland, 05-825 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum St. Pölten St. Pölten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHUP, EPE - Hospital de Santo Antonio Porto, Portugal, 4099-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Takatsuki Red Cross Hospital Takatsuki, Japan, 569-1096 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations R.I.A.C Naha City Hospital Naha, Japan, 902-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hyogo Prefectural Amagasaki General Medical Center Amagasaki, Japan, 660-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukui Prefectural Hospital Fukui, Japan, 910-8526 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokushima Prefectural Central Hospital Tokushima, Japan, 770-8539 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kanazawa Medical Center Kanazawa, Japan, 920-8650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Minamino Cardiovascular Hospital Hachioji, Japan, 192-0918 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Okayama Rosai Hospital Okayama, Japan, 702-8055 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka Medical College Hospital Takatsuki, Japan, 569-8686 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shonan Fujisawa Tokushukai Hospital Fujisawa, Japan, 251-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Louis Heart & Vascular, PC St. Louis, United States, 63136 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chuno kosei Hospital Seki, Japan, 501-3802 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
6
Primary Outcome
- Absolute change from baseline in 6MWD after 20 weeks of treatment6MWD: 6-minute walking distanceTimeframe: At 20 weeks of treatment
Secondary Outcome
- Absolute change in activity from baseline to 20 weeksActivity 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.Timeframe: 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 pressuresNT-proBNP: N-terminal pro-hormone b-type natriuretic peptideTimeframe: 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 injuryhs-TNT: high sensitivity troponin TTimeframe: At 20 weeks of treatment
- KCCQ (Kansas City cardiomyopathy questionnaire), measured values and absolute / relative change from baselineThe 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.Timeframe: At 20 weeks of treatment
Additional Information
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