Clinical trial NCT03098979: A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Chronic Heart Failure
Heart Failure with Preserved Ejection Fraction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 305
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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%)

Primary outcomes:
measure: Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
timeFrame: Baseline, and up to 20 weeks of treatment
Secondary outcomes:
measure: Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity
timeFrame: Baseline, and up to 20 weeks of treatment
measure: Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks
timeFrame: Baseline, and up to 20 weeks of treatment
measure: Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks
timeFrame: Baseline, and up to 20 weeks of treatment
measure: Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
timeFrame: Baseline, and up to 20 weeks of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Saint Louis
country: United States
facility: St. Louis Heart & Vascular, PC
state: Missouri
city: Lincoln
country: United States
facility: BryanLGH Medical Center East
state: Nebraska
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
state: Niederösterreich
city: Braunau
country: Austria
facility: Krankenhaus St. Josef Braunau
state: Oberösterreich
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz GmbH
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Roeselare
country: Belgium
facility: AZ Delta
city: Pernik
country: Bulgaria
facility: Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
city: Pleven
country: Bulgaria
facility: Specialized Hospital for Actrive Treatm of Card - Pleven
city: Sofia
country: Bulgaria
facility: Medical Center Cardiohelp
city: Sofia
country: Bulgaria
facility: NMTH Tzar Boris III
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Joanna-ISUL EAD Sofia
city: Stara Zagora
country: Bulgaria
facility: MCOMH Preventsia-2000
city: Mainz
country: Germany
facility: St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
state: Sachsen
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt GmbH
state: Thüringen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum (CVK)
city: Kifisia / Athens
country: Greece
facility: KAT General Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: G. Gennimatas General State Hospital of Athens
city: Chalkida
country: Greece
facility: General Hospital of Chalkida
city: Nea Ionia / Athens
country: Greece
facility: Konstantopoulio General Hospital of Nea Ionia - Agia Olga
city: Thessaloniki
country: Greece
facility: Hippokration General Hospital of Thessaloniki
city: Voula
country: Greece
facility: Asklipieion General Hospital of Voulas
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Health Corporation
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Mount Scopus
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Zrifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Udine
country: Italy
facility: AAS 3 Friuli Alto Medio Collin
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: A.O.U. Sant'Andrea
state: Lazio
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
state: Lombardia
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: Lombardia
city: Torino
country: Italy
facility: A.O. Ordine Mauriziano
state: Piemonte
city: Sassari
country: Italy
facility: A.O.U. di Sassari
state: Sardegna
city: Arezzo
country: Italy
facility: AUSL Toscana Sud-Est
state: Toscana
city: Seki
country: Japan
facility: Chuno kosei Hospital
state: Gifu
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
state: Hyogo
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
state: Ishikawa
city: Fujisawa
country: Japan
facility: Shonan Fujisawa Tokushukai Hospital
state: Kanagawa
city: Naha
country: Japan
facility: R.I.A.C Naha City Hospital
state: Okinawa
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Hachioji
country: Japan
facility: Minamino Cardiovascular Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital
city: Okayama
country: Japan
facility: Okayama Rosai Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Tokushima
country: Japan
facility: Tokushima Prefectural Central Hospital
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Grodzisk Mazowiecki
country: Poland
facility: Szpital Zachodni w Grodzisku Mazowieckim
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. J. Dietla
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
city: Szczecin
country: Poland
facility: 109 Szpital Wojskowy z przychodnia SPZOZ
city: Warszawa
country: Poland
facility: Szpital Wolski im. dr Anny Gostynskiej SPZOZ
city: Wroclaw
country: Poland
facility: IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
city: Coimbra
country: Portugal
facility: CHUC - Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: CHLO - Hospital São Francisco Xavier
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Porto
country: Portugal
facility: CHUP, EPE - Hospital de Santo Antonio
city: Aravaca
country: Spain
facility: Hospital Sanitas La Zarzuela
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Universitario "Virgen de la Arrixaca"
state: Murcia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Shah SJ, Voors AA, McMurray JJV, Kitzman DW, Viethen T, Bomfim Wirtz A, Huang E, Pap AF, Solomon SD. Effect of Neladenoson Bialanate on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2101-2112. doi: 10.1001/jama.2019.6717.