Skip to main content
OpenTrials
Completed

NCT Number: NCT02992288

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

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AZ St-Jan Brugge Oostende AV, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women aged 18 years and older
  • Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP

Exclusion criteria

  • Acute de-novo heart failure
  • Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
  • Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
  • Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy

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 Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography

    Time frame: Baseline, Week 20

    Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.

  2. Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20

    Time frame: Baseline, Week 20

    NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.

Secondary outcomes

  1. Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20

    Time frame: Baseline, Week 20

    LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.

  2. Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20

    Time frame: Baseline, Week 20

    LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.

  3. Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20

    Time frame: Baseline, Week 20

    High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.

  4. Number of Participants With Composite Efficacy Outcome

    Time frame: Baseline up to Week 26

    Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.

  5. Number of Participants With Cardiovascular (CV) Mortality

    Time frame: Baseline up to Week 26

    Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.

  6. Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)

    Time frame: Baseline up to Week 26

    Number of participants with HF hospitalization and urgent visits for HF were reported.

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, Pharmacokinetic and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Acronym: PANTHEON

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2016
Registry last updated
Apr 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.