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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
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Neladenoson bialanate (BAY1067197) Drug: Placebo Phase 2

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Neladenoson bialanate (BAY1067197) (5 mg)
Chronic heart failure with preserved ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks

Experimental: Neladenoson bialanate (BAY1067197) (10 mg)
Chronic heart failure with preserved ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks

Experimental: Neladenoson bialanate (BAY1067197) (20 mg)
Chronic heart failure with preserved ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks

Experimental: Neladenoson bialanate (BAY1067197) (30 mg)
Chronic heart failure with preserved ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks

Experimental: Neladenoson bialanate (BAY1067197) (40 mg)
Chronic heart failure with preserved ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks

Placebo Comparator: Placebo
Chronic heart failure with preserved ejection fraction
Drug: Placebo
Orally once daily for 20 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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".

  2. 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

  3. 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

  4. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%)

Information from the National Library of Medicine

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


  Show 76 Study Locations
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Statistical Analysis Plan  [PDF] June 15, 2018
Study Protocol  [PDF] February 14, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03098979     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Chronic Heart Failure
Heart Failure with Preserved Ejection Fraction

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Adenosine A1 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs