A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction (PANACHE)
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| ClinicalTrials.gov Identifier: NCT03098979 |
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Recruitment Status :
Completed
First Posted : April 4, 2017
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Drug: Neladenoson bialanate (BAY1067197) Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 305 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | May 10, 2017 |
| Actual Primary Completion Date : | May 23, 2018 |
| Actual Study Completion Date : | June 20, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Neladenoson bialanate (BAY1067197) (5 mg)
Chronic heart failure with preserved ejection fraction
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Drug: Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks |
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Experimental: Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with preserved ejection fraction
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Drug: Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks |
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Experimental: Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with preserved ejection fraction
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Drug: Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks |
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Experimental: Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with preserved ejection fraction
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Drug: Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks |
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Experimental: Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with preserved ejection fraction
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Drug: Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks |
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Placebo Comparator: Placebo
Chronic heart failure with preserved ejection fraction
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Drug: Placebo
Orally once daily for 20 weeks |
- 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 ]The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
- Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity [ Time Frame: Baseline, and up to 20 weeks of treatment ]AVIVO™ Mobile Patient Management System, a wearable wireless device worn by the subject, was used to monitor subjects' cardiovascular status. The patient's everyday physical activity e.g. duration, intensity, was also tracked by the AVIVO device. For Activity Intensity, the Unit of Measure is "percentage of maximum activity", and length of intervals is "daily".
- 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 ]NT-proBNP = N-terminal pro-hormone b-type natriuretic peptide
- 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 ]High sensitivity troponin T (hs-TNT) was measured
- 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 ]
The KCCQ is the leading health-related quality-of-life measure for patients with chronic heart failure (CHF). It is a 23-item questionnaire that independently measures the impact of patient's heart failure (HF), or its treatment, on 7 distinct domains: 1) Symptom Frequency 2) Symptom Burden 3) Physical Limitation 4) Quality of Life 5) Social Limitations 6) Self-efficacy 7) Symptoms Stability.
Overall summary score= mean score of (symptom frequency + symptom burden+ physical limitation + quality of life + social limitation); scores on a scale of 0 to 100, higher scores means better outcome; Physical Limitation: scores on a scale of 0 to 100, higher scores means better outcome; Total symptom score=mean score of (symptom frequency + symptom burden): scores on a scale of 0 to 100, higher scores means better outcome.
Positive change means improvement and negative change means deterioration.
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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%)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098979
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| Study Director: | Bayer Study Director | Bayer |
Documents provided by Bayer:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT03098979 |
| Other Study ID Numbers: |
17582 2016-004062-26 ( EudraCT Number ) |
| First Posted: | April 4, 2017 Key Record Dates |
| Results First Posted: | July 23, 2019 |
| Last Update Posted: | July 23, 2019 |
| Last Verified: | July 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Chronic Heart Failure Heart Failure with Preserved Ejection Fraction |
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Heart Failure Heart Diseases Cardiovascular Diseases |