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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03098979
• Date of registration: 15/03/2017
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction PANACHE
• Scientific title: 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
• Date of first enrolment: May 10, 2017
• Target sample size: 305
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03098979
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Bulgaria, Germany, Greece, Israel, Italy, Japan, Poland, Portugal, Spain, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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%)



Age minimum: 45 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Drug: Neladenoson bialanate (BAY1067197)

Drug: Placebo

Primary Outcome(s)

Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment [Time Frame: Baseline, and up to 20 weeks of treatment]

Secondary Outcome(s)

Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity [Time Frame: Baseline, and up to 20 weeks of treatment]

Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks [Time Frame: Baseline, and up to 20 weeks of treatment]

Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks [Time Frame: Baseline, and up to 20 weeks of treatment]

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 [Time Frame: Baseline, and up to 20 weeks of treatment]

Secondary ID(s)

17582

2016-004062-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03098979