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

Heart Failure Clinical Trial

— PANACHE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098979
• Other study ID #: 17582
• Secondary ID: 2016-004062-26
• Status: Completed
• Phase: Phase 2
• Start date: May 10, 2017
• Est. completion date: June 20, 2018

Study information

• Verified date: July 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 20, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks
• Placebo
Orally once daily for 20 weeks

Locations

Country	Name	City	State
Austria	Krankenhaus St. Josef Braunau	Braunau	Oberösterreich
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Krankenhaus der Elisabethinen Linz GmbH	Linz	Oberösterreich
Austria	Universitätsklinikum St. Pölten	St. Pölten	Niederösterreich
Austria	Allgemeines Krankenhaus der Stadt Wien	Wien
Austria	Krankenhaus Hietzing	Wien
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	CHR de la Citadelle	Liege
Belgium	AZ Delta	Roeselare
Bulgaria	Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik	Pernik
Bulgaria	Specialized Hospital for Actrive Treatm of Card - Pleven	Pleven
Bulgaria	Medical Center Cardiohelp	Sofia
Bulgaria	NMTH Tzar Boris III	Sofia
Bulgaria	UMHAT Tsaritsa Joanna-ISUL EAD Sofia	Sofia
Bulgaria	MCOMH Preventsia-2000	Stara Zagora
Germany	Charité Campus Virchow-Klinikum (CVK)	Berlin
Germany	Klinische Forschung Dresden GmbH	Dresden	Sachsen
Germany	HELIOS Klinikum Erfurt GmbH	Erfurt	Thüringen
Germany	St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz	Mainz	Rheinland-Pfalz
Greece	G. Gennimatas General State Hospital of Athens	Athens
Greece	General Hospital of Chalkida	Chalkida
Greece	KAT General Hospital of Athens	Kifisia / Athens	Attica
Greece	Konstantopoulio General Hospital of Nea Ionia - Agia Olga	Nea Ionia / Athens
Greece	Hippokration General Hospital of Thessaloniki	Thessaloniki
Greece	Asklipieion General Hospital of Voulas	Voula
Israel	Barzilai Medical Center	Ashkelon
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Rambam Health Corporation	Haifa
Israel	Hadassah University Hospital Mount Scopus	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Israel	Assaf Harofeh Medical Center	Zrifin
Italy	AUSL Toscana Sud-Est	Arezzo	Toscana
Italy	ASST Papa Giovanni XXIII	Bergamo	Lombardia
Italy	ASST Spedali Civili di Brescia	Brescia	Lombardia
Italy	A.O.U. Sant'Andrea	Roma	Lazio
Italy	A.O.U. di Sassari	Sassari	Sardegna
Italy	A.O. Ordine Mauriziano	Torino	Piemonte
Italy	AAS 3 Friuli Alto Medio Collin	Udine	Friuli-Venezia Giulia
Japan	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki	Hyogo
Japan	Shonan Fujisawa Tokushukai Hospital	Fujisawa	Kanagawa
Japan	Fukui Prefectural Hospital	Fukui
Japan	Minamino Cardiovascular Hospital	Hachioji	Tokyo
Japan	National Hospital Organization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Kishiwada Tokushukai Hospital	Kishiwada	Osaka
Japan	R.I.A.C Naha City Hospital	Naha	Okinawa
Japan	Okayama Rosai Hospital	Okayama
Japan	Osaka General Medical Center	Osaka
Japan	Chuno kosei Hospital	Seki	Gifu
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Osaka Medical College Hospital	Takatsuki	Osaka
Japan	Takatsuki Red Cross Hospital	Takatsuki	Osaka
Japan	Tokushima Prefectural Central Hospital	Tokushima
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Szpital Zachodni w Grodzisku Mazowieckim	Grodzisk Mazowiecki
Poland	Szpital Specjalistyczny im. J. Dietla	Krakow
Poland	Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego	Lodz
Poland	109 Szpital Wojskowy z przychodnia SPZOZ	Szczecin
Poland	Szpital Wolski im. dr Anny Gostynskiej SPZOZ	Warszawa
Poland	IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ	Wroclaw
Portugal	CHUC - Hospitais da Universidade de Coimbra	Coimbra
Portugal	CHLO - Hospital São Francisco Xavier	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	CHUP, EPE - Hospital de Santo Antonio	Porto
Spain	Hospital Sanitas La Zarzuela	Aravaca	Madrid
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario "Virgen de la Arrixaca"	El Palmar	Murcia
Spain	Hospital Clínico Universitario San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia
United States	Northwestern University	Chicago	Illinois
United States	BryanLGH Medical Center East	Lincoln	Nebraska
United States	St. Louis Heart & Vascular, PC	Saint Louis	Missouri
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Germany,  Greece,  Israel,  Italy,  Japan,  Poland,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, and up to 20 weeks of treatment
Secondary	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".	Baseline, and up to 20 weeks of treatment
Secondary	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	Baseline, and up to 20 weeks of treatment
Secondary	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	Baseline, and up to 20 weeks of treatment
Secondary	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.	Baseline, and up to 20 weeks of treatment