A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT02992288

Run by

Bayer

People needed

427

Starts

2017-02-22

Expected to finish

2018-05-16

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Henry Ford Health System — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• St. Louis Heart & Vascular, PC — St Louis, Missouri, United States
• Glacier View Research Institute-Cardiology — Kalispell, Montana, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• St. Elizabeth Youngstown Hospital — Youngstown, Ohio, United States
• Tennessee Center for Clinical Trials — Tullahoma, Tennessee, United States
• East Texas Cardiology — Houston, Texas, United States
• AZ St-Jan Brugge Oostende AV — Bruges, Belgium
• Grand Hôpital de Charleroi — Gilly, Belgium
• AZ Delta — Roeselare, Belgium
• AZ Turnhout — Turnhout, Belgium
• Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik — Pernik, Bulgaria
• Specialized Hospital for Actrive Treatm of Card - Pleven — Pleven, Bulgaria
• NMTH Tzar Boris III — Sofia, Bulgaria
• UMHAT Tsaritsa Joanna-ISUL EAD Sofia — Sofia, Bulgaria
• Multiprofile Hospital for Active Treatment Sveta Sofia — Sofia, Bulgaria
• MHAT Dr Stefan Cherkezov — Veliko Tarnovo, Bulgaria
• Medizinische Hochschule Hannover (MHH) — Hanover, Lower Saxony, Germany
• Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) — Bad Oeynhausen, North Rhine-Westphalia, Germany
• St.-Johannes-Hospital Dortmund — Dortmund, North Rhine-Westphalia, Germany
• Kliniken Maria Hilf GmbH — Mönchengladbach, North Rhine-Westphalia, Germany
• Klinikum der Stadt Ludwigshafen am Rhein gGmbH — Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
• Charité Campus Virchow-Klinikum (CVK) — Berlin, Germany
• Southwest Florida Research — Naples, Florida, United States

Full record on ClinicalTrials.gov

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