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

Bayer

Status and phase: Completed; Phase 2

Conditions: Heart Failure

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03098979

17582

2016-004062-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 305 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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305 participants in 6 patient groups, including a placebo group

Neladenoson bialanate (BAY1067197) (5 mg)

Experimental group

Description:

Chronic heart failure with preserved 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 preserved 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 preserved 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 preserved 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 preserved 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 preserved ejection fraction

Treatment:

Drug: Placebo