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 | |
|---|---|
Locations UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia, Bulgaria, 1527 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NMTH Tzar Boris III Sofia, Bulgaria, 1233 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MCOMH Preventsia-2000 Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Specialized Hospital for Actrive Treatm of Card - Pleven Pleven, Bulgaria, 5800 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OOD Pernik, Bulgaria, 2300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jessa Ziekenhuis HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHR de la Citadelle Liege, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations G. GENNIMATAS General State Hospital of Athens Athens, Greece, 11527 | 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 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations KAT General Hospital of Athens Kifisia / Athens, Greece, 14561 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asklipieion General Hospital of Voulas Voula, Greece, 16673 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center Cardiohelp Sofia, Bulgaria, 1142 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations General Hospital of Chalkida Chalkida, Greece, 34100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27157-1045 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations BryanLGH Medical Center East Lincoln, United States, 68506 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northwestern University Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AUSL Toscana Sud-Est Arezzo, Italy, 52044 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AAS 3 Friuli Alto Medio Collin Udine, Italy, 33038 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Sant'Andrea Roma, Italy, 00189 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Sassari Sassari, Italy, 07100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O. Ordine Mauriziano Torino, Italy, 10128 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ordensklinikum Linz GmbH Elisabethinen Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinik Hietzing Wien, Austria, 1130 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shamir Medical Center (Assaf Harofeh) Zrifin, Israel, 7030000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 9103102 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hillel Yaffe Medical Center Hadera, Israel, 3810101 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hadassah University Hospital Mount Scopus Jerusalem, Israel | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus St. Josef Braunau Braunau, Austria, 5280 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital da Luz - Lisboa Lisboa, Portugal, 1500-650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHUC - Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHLO - Hospital Sao Francisco Xavier Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 109 Szpital Wojskowy z przychodnia SPZOZ Szczecin, Poland, 70-965 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ Wroclaw, Poland, 50-981 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Sanitas La Zarzuela Aravaca, Spain, 28023 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke El Palmar, Spain, 30120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Charité - Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HELIOS Klinikum Erfurt GmbH Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinische Forschung Dresden GmbH Dresden, Germany, 01069 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Marienhaus Klinikum Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Specjalistyczny im. J. Dietla Krakow, Poland, 31-121 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego Lodz, Poland, 91-347 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Wolski im. dr Anny Gostynskiej SPZOZ Warszawa, Poland, 02-211 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Samodzielny Publiczny Specjalistyczny Szpital Zachodni Grodzisk Mazowiecki, Poland, 05-825 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum St. Pölten St. Pölten, Austria, 3100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Takatsuki Red Cross Hospital Takatsuki, Japan, 569-1096 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations R.I.A.C Naha City Hospital Naha, Japan, 902-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-0042 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hyogo Prefectural Amagasaki General Medical Center Amagasaki, Japan, 660-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukui Prefectural Hospital Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokushima Prefectural Central Hospital Tokushima, Japan, 770-8539 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kanazawa Medical Center Kanazawa, Japan, 920-8650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Minamino Cardiovascular Hospital Hachioji, Japan, 192-0918 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Okayama Rosai Hospital Okayama, Japan, 702-8055 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka Medical College Hospital Takatsuki, Japan, 569-8686 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shonan Fujisawa Tokushukai Hospital Fujisawa, Japan, 251-0041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Louis Heart & Vascular, PC St. Louis, United States, 63136 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chuno kosei Hospital Seki, Japan, 501-3802 | 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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