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Completed

NCT Number: NCT03098979

A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum St. Pölten, Sankt Pölten, Lower Austria, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Neladenoson bialanate (BAY1067197)

Drug

5 mg orally once daily for 20 weeks

Placebo

Drug

Orally once daily for 20 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: PANACHE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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