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

Bayer

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: Neladenoson bialanate (BAY1067197)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02992288

15128

2016-003839-38 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 427 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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427 participants in 6 patient groups, including a placebo group

Neladenoson bialanate (BAY1067197) (5 mg)

Experimental group

Description:

Chronic heart failure with reduced ejection fraction

Treatment:

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Neladenoson bialanate (BAY1067197) (10 mg)

Experimental group

Description:

Chronic heart failure with reduced ejection fraction

Treatment:

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Neladenoson bialanate (BAY1067197) (20 mg)

Experimental group

Description:

Chronic heart failure with reduced ejection fraction

Treatment:

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Neladenoson bialanate (BAY1067197) (30 mg)

Experimental group

Description:

Chronic heart failure with reduced ejection fraction

Treatment:

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Neladenoson bialanate (BAY1067197) (40 mg)

Experimental group

Description:

Chronic heart failure with reduced ejection fraction

Treatment:

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Neladenoson bialanate (BAY1067197)

Placebo

Placebo Comparator group

Description:

Chronic heart failure with reduced ejection fraction

Treatment:

Drug: Placebo