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:

NCT03098979

EudraCT Number:

2016-004062-26

Study Completed

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
305
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Neladenoson Bialanate (BAY1067197)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

UMHAT Tsaritsa Joanna-ISUL EAD Sofia

Sofia, Bulgaria, 1527

Status
Completed
 
Locations

NMTH Tzar Boris III

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

MCOMH Preventsia-2000

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Specialized Hospital for Actrive Treatm of Card - Pleven

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

Pernik, Bulgaria, 2300

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Jessa Ziekenhuis

HASSELT, Belgium, 3500

Status
Completed
 
Locations

CHR de la Citadelle

LIEGE, Belgium, 4000

Status
Completed
 
Locations

AZ Delta

ROESELARE, Belgium, 8800

Status
Completed
 
Locations

G. Gennimatas General State Hospital of Athens

Athens, Greece, 11527

Status
Completed
 
Locations

Konstantopoulio General Hospital of Nea Ionia - Agia Olga

Nea Ionia / Athens, Greece, 142 33

Status
Completed
 
Locations

KAT General Hospital of Athens

Kifisia / Athens, Greece, 14561

Status
Completed
 
Locations

Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece, 54642

Status
Completed
 
Locations

Asklipieion General Hospital of Voulas

Voula, Greece, 16673

Status
Completed
 
Locations

Medical Center Cardiohelp

Sofia, Bulgaria, 1142

Status
Completed
 
Locations

General Hospital of Chalkida

Chalkida, Greece, 34100

Status
Completed
 
Locations

Wake Forest Baptist Health

Winston-Salem, United States, 27157-1045

Status
Completed
 
Locations

BryanLGH Medical Center East

Lincoln, United States, 68506

Status
Completed
 
Locations

Northwestern University

Chicago, United States, 60611

Status
Completed
 
Locations

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Status
Completed
 
Locations

AUSL Toscana Sud-Est

Arezzo, Italy, 52040

Status
Completed
 
Locations

ASST Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
 
Locations

AAS 3 Friuli Alto Medio Collin

Udine, Italy, 33038

Status
Completed
 
Locations

A.O. Sant'Andrea

Roma, Italy, 00189

Status
Completed
 
Locations

A.O.U. di Sassari

Sassari, Italy, 07100

Status
Completed
 
Locations

A.O. Ordine Mauriziano

Torino, Italy, 10128

Status
Completed
 
Locations

Krankenhaus der Elisabethinen Linz GmbH

Linz, Austria, 4020

Status
Completed
 
Locations

Krankenhaus Hietzing

Wien, Austria, 1130

Status
Completed
 
Locations

Assaf Harofeh Medical Center

Zrifin, Israel, 6093000

Status
Completed
 
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Completed
 
Locations

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Status
Completed
 
Locations

Hillel Yaffe Medical Center

Hadera, Israel, 3810101

Status
Completed
 
Locations

Hadassah University Hospital Mount Scopus

Jerusalem, Israel

Status
Completed
 
Locations

Rambam Health Corporation

Haifa, Israel, 3109601

Status
Completed
 
Locations

Krankenhaus St. Josef Braunau

Braunau, Austria, 5280

Status
Completed
 
Locations

Hospital da Luz

Lisboa, Portugal, 1500-650

Status
Completed
 
Locations

CHUC - Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000-075

Status
Completed
 
Locations

CHLO - Hospital São Francisco Xavier

Lisboa, Portugal, 1449-005

Status
Completed
 
Locations

109 Szpital Wojskowy z przychodnia SPZOZ

Szczecin, Poland, 70-965

Status
Completed
 
Locations

IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

Wroclaw, Poland, 50-981

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Completed
 
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Recruiting
 
Locations

Hospital Universitario "Virgen de la Arrixaca"

El Palmar, Spain, 30120

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Completed
 
Locations

Klinische Forschung Dresden GmbH

Dresden, Germany, 01069

Status
Completed
 
Locations

St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

Szpital Specjalistyczny im. J. Dietla

Krakow, Poland, 31-121

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego

Lodz, Poland, 91-347

Status
Completed
 
Locations

Szpital Wolski im. dr Anny Gostynskiej SPZOZ

Warszawa, Poland, 02-211

Status
Completed
 
Locations

Szpital Zachodni w Grodzisku Mazowieckim

Grodzisk Mazowiecki, Poland, 05-825

Status
Completed
 
Locations

Universitätsklinikum St. Pölten

St. Pölten, Austria, 3100

Status
Completed
 
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status
Completed
 
Locations

CHUP, EPE - Hospital de Santo Antonio

Porto, Portugal, 4099-001

Status
Completed
 
Locations

Takatsuki Red Cross Hospital

Takatsuki, Japan, 569-1096

Status
Completed
 
Locations

R.I.A.C Naha City Hospital

Naha, Japan, 902-8511

Status
Completed
 
Locations

Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-8522

Status
Completed
 
Locations

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Japan, 660-8550

Status
Completed
 
Locations

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

Status
Completed
 
Locations

Tokushima Prefectural Central Hospital

Tokushima, Japan, 770-8539

Status
Completed
 
Locations

National Hospital Organization Kanazawa Medical Center

Kanazawa, Japan, 920-8650

Status
Completed
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Minamino Cardiovascular Hospital

Hachioji, Japan, 192-0918

Status
Completed
 
Locations

Okayama Rosai Hospital

Okayama, Japan, 702-8055

Status
Completed
 
Locations

Osaka Medical College Hospital

Takatsuki, Japan, 569-8686

Status
Completed
 
Locations

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Japan, 251-0041

Status
Completed
 
Locations

St. Louis Heart & Vascular, PC

St. Louis, United States, 63136

Status
Completed
 
Locations

Chuno kosei Hospital

Seki, Japan, 501-3802

Status
Completed
 

Trial Design