Phase 2
Completed N=305
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov NCT03098979 ↗Enrolled (actual)
305
Serious AEs
26.9%
Results posted
Jul 2019
Primary outcomePrimary: Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment — 329; 306; 300; 328 meter — p=0.5183
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment |
329; 306; 300; 328; 321; 363 | 0.5183 |
| SECONDARY Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity |
2.83; 2.76; 2.83; 2.51; 2.61; 2.43 | — |
| SECONDARY Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks |
6.80; 6.78; 6.81; 6.73; 6.68; 6.64 | — |
| SECONDARY Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks |
2.92; 3.25; 2.95; 2.76; 2.73; 2.76 | — |
| SECONDARY Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score |
69.19; 64.75; 66.42; 64.57; 63.67; 64.65 | — |
Eligibility Criteria
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%)
Data sourced from ClinicalTrials.gov (NCT03098979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.