AzTrials
AzTrials

Heart FailurePhase 2PANACHENCT03098979

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

A Phase 2 study testing Neladenoson bialanate (BAY1067197) in people with Heart Failure, run by Bayer at 76 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Heart Failure
What is being tested?
Neladenoson bialanate (BAY1067197)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
76 sitesin 12 countries
Study dates
10 May 2017to 20 Jun 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Acute decompensated heart failure within the past 4 weeks
  • Inability to exercise
  • Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)

Trial locations and contacts

76 sites in 12 countries.

76 sites in 12 countries

Japan14 sites

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyōgo, 660-8550

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa, Kanagawa, 251-0041

  • Fukui Prefectural Hospital

    Fukui, 910-8526

  • Minamino Cardiovascular Hospital

    Hachiōji, Tokyo, 192-0918

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, 596-8522

  • R.I.A.C Naha City Hospital

    Naha, Okinawa, 902-8511

  • Okayama Rosai Hospital

    Okayama, 702-8055

  • Osaka General Medical Center

    Osaka, 558-8558

  • Chuno kosei Hospital

    Sekimachi, Gifu, 501-3802

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • Takatsuki Red Cross Hospital

    Takatsuki, Osaka, 569-1096

  • Osaka Medical College Hospital

    Takatsuki, Osaka, 569-8686

  • Tokushima Prefectural Central Hospital

    Tokushima, 770-8539

Other trials in Japan

Spain8 sites

  • Hospital Sanitas La Zarzuela

    Aravaca, Madrid, 28023

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario "Virgen de la Arrixaca"

    El Palmar, Murcia, 30120

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

Israel7 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Rambam Health Corporation

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital Mount Scopus

    Jerusalem

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Harofeh Medical Center

    Zrifin, 6093000

Other trials in Israel

Italy7 sites

  • AUSL Toscana Sud-Est

    Arezzo, Tuscany, 52040

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • A.O.U. Sant'Andrea

    Rome, Lazio, 00189

  • A.O.U. di Sassari

    Sassari, Sardinia, 07100

  • A.O. Ordine Mauriziano

    Turin, Piedmont, 10128

  • AAS 3 Friuli Alto Medio Collin

    Udine, Friuli Venezia Giulia, 33038

Other trials in Italy

Poland7 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Szpital Zachodni w Grodzisku Mazowieckim

    Grodzisk Mazowiecki, 05-825

  • Szpital Specjalistyczny im. J. Dietla

    Krakow, 31-121

  • Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego

    Lodz, 91-347

  • 109 Szpital Wojskowy z przychodnia SPZOZ

    Szczecin, 70-965

  • Szpital Wolski im. dr Anny Gostynskiej SPZOZ

    Warsaw, 02-211

  • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

    Wroclaw, 50-981

Other trials in Poland

Austria6 sites

  • Krankenhaus St. Josef Braunau

    Braunau am Inn, Upper Austria, 5280

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, Upper Austria, 4020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 1090

  • Krankenhaus Hietzing

    Vienna, 1130

Other trials in Austria

Bulgaria6 sites

  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

    Pernik, 2300

  • Specialized Hospital for Actrive Treatm of Card - Pleven

    Pleven, 5800

  • Medical Center Cardiohelp

    Sofia, 1142

  • NMTH Tzar Boris III

    Sofia, 1233

  • UMHAT Tsaritsa Joanna-ISUL EAD Sofia

    Sofia, 1527

  • MCOMH Preventsia-2000

    Stara Zagora, 6000

Other trials in Bulgaria

Greece6 sites

  • G. Gennimatas General State Hospital of Athens

    Athens, 11527

  • General Hospital of Chalkida

    Chalcis, 34100

  • KAT General Hospital of Athens

    Kifisia / Athens, Attica, 14561

  • Konstantopoulio General Hospital of Nea Ionia - Agia Olga

    Nea Ionia / Athens, 142 33

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, 54642

  • Asklipieion General Hospital of Voulas

    Voula, 16673

Other trials in Greece

United States4 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • BryanLGH Medical Center East

    Lincoln, Nebraska, 68506

  • St. Louis Heart & Vascular, PC

    St Louis, Missouri, 63136

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157-1045

Other trials in United States

Germany4 sites

  • Charité Campus Virchow-Klinikum (CVK)

    Berlin, 13353

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony, 01069

  • HELIOS Klinikum Erfurt GmbH

    Erfurt, Thuringia, 99089

  • St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Portugal4 sites

  • CHUC - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • CHLO - Hospital São Francisco Xavier

    Lisbon, 1449-005

  • Hospital da Luz

    Lisbon, 1500-650

  • CHUP, EPE - Hospital de Santo Antonio

    Porto, 4099-001

Other trials in Portugal

Belgium3 sites

  • Jessa Ziekenhuis

    Hasselt, 3500

  • CHR de la Citadelle

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

About this study

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

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.

Conditions
Heart Failure
Being tested
Neladenoson bialanate (BAY1067197), Placebo
Keywords
Chronic Heart Failure, Heart Failure with Preserved Ejection Fraction
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neladenoson bialanate (BAY1067197)Drug

    5 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    10 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    20 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    30 mg orally once daily for 20 weeks

  • Neladenoson bialanate (BAY1067197)Drug

    40 mg orally once daily for 20 weeks

  • PlaceboDrug

    Orally once daily for 20 weeks

Study groups in NCT03098979
Study groupRoleWhat they receive
Neladenoson bialanate (BAY1067197) (5 mg)ExperimentalChronic heart failure with preserved ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (10 mg)ExperimentalChronic heart failure with preserved ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (20 mg)ExperimentalChronic heart failure with preserved ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (30 mg)ExperimentalChronic heart failure with preserved ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (40 mg)ExperimentalChronic heart failure with preserved ejection fraction
Receives: Drug: Neladenoson bialanate (BAY1067197)
PlaceboPlacebo comparatorChronic heart failure with preserved ejection fraction
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment

    The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.

    Measured: Baseline, and up to 20 weeks of treatment

Secondary outcomes (4)

  1. Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity

    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: Baseline, and up to 20 weeks of treatment

  2. Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks

    NT-proBNP = N-terminal pro-hormone b-type natriuretic peptide

    Measured: Baseline, and up to 20 weeks of treatment

  3. Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks

    High sensitivity troponin T (hs-TNT) was measured

    Measured: Baseline, and up to 20 weeks of treatment

  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

    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.

    Measured: Baseline, and up to 20 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start10 May 2017
  3. Primary completion23 May 2018
  4. Study completion20 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03098979
Sponsor's protocol ID
17582
Other IDs
2016-004062-26, 2016
Acronym
PANACHE
Status last verified
Jul 2019
First submitted
15 Mar 2017
Last updated
23 Jul 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Shah SJ, Voors AA, McMurray JJV, Kitzman DW, Viethen T, Bomfim Wirtz A, Huang E, Pap AF, Solomon SD. Effect of Neladenoson Bialanate on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2101-2112. doi: 10.1001/jama.2019.6717.

    PubMed 31162568

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neladenoson bialanate (BAY1067197) in people with Heart Failure, run by Bayer at 76 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Japan, Spain, Israel, Italy, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098979, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in