A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 6/27/2018 |
| Start Date: | May 10, 2017 |
| End Date: | June 20, 2018 |
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
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.
bialanate (BAY1067197) when given in addition to appropriate therapy for specific
comorbidities.
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%)
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