A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction (PANACHE)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Chronic Heart Failure, Heart Failure with Preserved Ejection Fraction
Eligibility Criteria
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%)
Sites / Locations
- Northwestern University
- St. Louis Heart & Vascular, PC
- BryanLGH Medical Center East
- Wake Forest Baptist Health
- Universitätsklinikum St. Pölten
- Krankenhaus St. Josef Braunau
- Krankenhaus der Elisabethinen Linz GmbH
- Medizinische Universität Graz
- Allgemeines Krankenhaus der Stadt Wien
- Krankenhaus Hietzing
- Jessa Ziekenhuis
- CHR de la Citadelle
- AZ Delta
- Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
- Specialized Hospital for Actrive Treatm of Card - Pleven
- Medical Center Cardiohelp
- NMTH Tzar Boris III
- UMHAT Tsaritsa Joanna-ISUL EAD Sofia
- MCOMH Preventsia-2000
- St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
- Klinische Forschung Dresden GmbH
- HELIOS Klinikum Erfurt GmbH
- Charité Campus Virchow-Klinikum (CVK)
- KAT General Hospital of Athens
- G. Gennimatas General State Hospital of Athens
- General Hospital of Chalkida
- Konstantopoulio General Hospital of Nea Ionia - Agia Olga
- Hippokration General Hospital of Thessaloniki
- Asklipieion General Hospital of Voulas
- Barzilai Medical Center
- Hillel Yaffe Medical Center
- Rambam Health Corporation
- Shaare Zedek Medical Center
- Hadassah University Hospital Mount Scopus
- Tel-Aviv Sourasky Medical Center
- Assaf Harofeh Medical Center
- AAS 3 Friuli Alto Medio Collin
- A.O.U. Sant'Andrea
- ASST Papa Giovanni XXIII
- ASST Spedali Civili di Brescia
- A.O. Ordine Mauriziano
- A.O.U. di Sassari
- AUSL Toscana Sud-Est
- Chuno kosei Hospital
- Hyogo Prefectural Amagasaki General Medical Center
- National Hospital Organization Kanazawa Medical Center
- Shonan Fujisawa Tokushukai Hospital
- R.I.A.C Naha City Hospital
- Kishiwada Tokushukai Hospital
- Takatsuki Red Cross Hospital
- Osaka Medical College Hospital
- Minamino Cardiovascular Hospital
- Tokyo Women's Medical University Hospital
- Fukui Prefectural Hospital
- Okayama Rosai Hospital
- Osaka General Medical Center
- Tokushima Prefectural Central Hospital
- Uniwersytecki Szpital Kliniczny w Bialymstoku
- Szpital Zachodni w Grodzisku Mazowieckim
- Szpital Specjalistyczny im. J. Dietla
- Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
- 109 Szpital Wojskowy z przychodnia SPZOZ
- Szpital Wolski im. dr Anny Gostynskiej SPZOZ
- IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
- CHUC - Hospitais da Universidade de Coimbra
- CHLO - Hospital São Francisco Xavier
- Hospital da Luz
- CHUP, EPE - Hospital de Santo Antonio
- Hospital Sanitas La Zarzuela
- Hospital Universitario "Virgen de la Arrixaca"
- Hospital del Mar
- Hospital General Universitario Gregorio Marañón
- Hospital Clínico Universitario San Carlos
- Hospital Virgen de la Victoria
- Hospital Clínico Universitario de Valencia
- Hospital Universitari i Politècnic La Fe
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Neladenoson bialanate (BAY1067197) (5 mg)
Neladenoson bialanate (BAY1067197) (10 mg)
Neladenoson bialanate (BAY1067197) (20 mg)
Neladenoson bialanate (BAY1067197) (30 mg)
Neladenoson bialanate (BAY1067197) (40 mg)
Placebo
Chronic heart failure with preserved ejection fraction
Chronic heart failure with preserved ejection fraction
Chronic heart failure with preserved ejection fraction
Chronic heart failure with preserved ejection fraction
Chronic heart failure with preserved ejection fraction
Chronic heart failure with preserved ejection fraction