Clinical trial NCT02992288: A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Chronic Heart Failure
Heart Failure with Reduced Ejection Fraction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-14
Enrollment: 427
Sex: ALL
Minimum age (years): 18
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 (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).


Eligibility criteria: Inclusion Criteria:

* Men or women aged 18 years and older
* Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP

Exclusion Criteria:

* Acute de-novo heart failure
* Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
* Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
* Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy

Primary outcomes:
measure: Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
timeFrame: Baseline, Week 20
measure: Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
timeFrame: Baseline, Week 20
Secondary outcomes:
measure: Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
timeFrame: Baseline, Week 20
measure: Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
timeFrame: Baseline, Week 20
measure: Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
timeFrame: Baseline, Week 20
measure: Number of Participants With Composite Efficacy Outcome
timeFrame: Baseline up to Week 26
measure: Number of Participants With Cardiovascular (CV) Mortality
timeFrame: Baseline up to Week 26
measure: Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
timeFrame: Baseline up to Week 26
Other outcomes:
Locations:
city: Naples
country: United States
facility: Southwest Florida Research
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Heart & Vascular, PC
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute-Cardiology
state: Montana
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Youngstown
country: United States
facility: St. Elizabeth Youngstown Hospital
state: Ohio
city: Tullahoma
country: United States
facility: Tennessee Center for Clinical Trials
state: Tennessee
city: Houston
country: United States
facility: East Texas Cardiology
state: Texas
city: Brugge
country: Belgium
facility: AZ St-Jan Brugge Oostende AV
city: Gilly
country: Belgium
facility: Grand Hôpital de Charleroi
city: Roeselare
country: Belgium
facility: AZ Delta
city: Turnhout
country: Belgium
facility: AZ Turnhout
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: NMTH Tzar Boris III
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Joanna-ISUL EAD Sofia
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sveta Sofia
city: Veliko Tarnovo
country: Bulgaria
facility: MHAT Dr Stefan Cherkezov
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
state: Niedersachsen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital Dortmund
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
state: Rheinland-Pfalz
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: Elefsina
country: Greece
facility: Thriassio General Hospital of Elefsina
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: 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: Napoli
country: Italy
facility: A.O.U. Policlinico Federico II Napoli
state: Campania
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
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: Milano
country: Italy
facility: IRCCS Centro Cardiologico Fondazione Monzino
state: Lombardia
city: Arezzo
country: Italy
facility: AUSL 8 Arezzo
state: Toscana
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Takasaki
country: Japan
facility: National Hospital Organization Takasaki General Medical C
state: Gunma
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
state: Hyogo
city: Higashiibaraki
country: Japan
facility: National hospital Organization Mito Medical Center
state: Ibaraki
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: Hachioji
country: Japan
facility: Minamino Cardiovascular Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Okayama
country: Japan
facility: Okayama Rosai Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Katowice
country: Poland
facility: CLINICAL MEDICAL RESEARCH Sp. z o. o.
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. J. Dietla
city: Lodz
country: Poland
facility: Nzoz Salus
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Wroclaw
country: Poland
facility: IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: El Palmar
country: Spain
facility: Hospital Universitario "Virgen de la Arrixaca"
state: Murcia
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
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: Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, Butler J; PANTHEON Investigators. Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2019 Nov;21(11):1426-1433. doi: 10.1002/ejhf.1591. Epub 2019 Sep 16.