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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Chronic Heart Failure, Heart Failure with Preserved Ejection Fraction

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Northwestern University
  • St. Louis Heart & Vascular, PC
  • BryanLGH Medical Center East
  • Wake Forest Baptist Health
  • Universitätsklinikum St. Pölten
  • Krankenhaus St. Josef Braunau
  • Krankenhaus der Elisabethinen Linz GmbH
  • Medizinische Universität Graz
  • Allgemeines Krankenhaus der Stadt Wien
  • Krankenhaus Hietzing
  • Jessa Ziekenhuis
  • CHR de la Citadelle
  • AZ Delta
  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
  • Specialized Hospital for Actrive Treatm of Card - Pleven
  • Medical Center Cardiohelp
  • NMTH Tzar Boris III
  • UMHAT Tsaritsa Joanna-ISUL EAD Sofia
  • MCOMH Preventsia-2000
  • St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
  • Klinische Forschung Dresden GmbH
  • HELIOS Klinikum Erfurt GmbH
  • Charité Campus Virchow-Klinikum (CVK)
  • KAT General Hospital of Athens
  • G. Gennimatas General State Hospital of Athens
  • General Hospital of Chalkida
  • Konstantopoulio General Hospital of Nea Ionia - Agia Olga
  • Hippokration General Hospital of Thessaloniki
  • Asklipieion General Hospital of Voulas
  • Barzilai Medical Center
  • Hillel Yaffe Medical Center
  • Rambam Health Corporation
  • Shaare Zedek Medical Center
  • Hadassah University Hospital Mount Scopus
  • Tel-Aviv Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • AAS 3 Friuli Alto Medio Collin
  • A.O.U. Sant'Andrea
  • ASST Papa Giovanni XXIII
  • ASST Spedali Civili di Brescia
  • A.O. Ordine Mauriziano
  • A.O.U. di Sassari
  • AUSL Toscana Sud-Est
  • Chuno kosei Hospital
  • Hyogo Prefectural Amagasaki General Medical Center
  • National Hospital Organization Kanazawa Medical Center
  • Shonan Fujisawa Tokushukai Hospital
  • R.I.A.C Naha City Hospital
  • Kishiwada Tokushukai Hospital
  • Takatsuki Red Cross Hospital
  • Osaka Medical College Hospital
  • Minamino Cardiovascular Hospital
  • Tokyo Women's Medical University Hospital
  • Fukui Prefectural Hospital
  • Okayama Rosai Hospital
  • Osaka General Medical Center
  • Tokushima Prefectural Central Hospital
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Szpital Zachodni w Grodzisku Mazowieckim
  • Szpital Specjalistyczny im. J. Dietla
  • Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
  • 109 Szpital Wojskowy z przychodnia SPZOZ
  • Szpital Wolski im. dr Anny Gostynskiej SPZOZ
  • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
  • CHUC - Hospitais da Universidade de Coimbra
  • CHLO - Hospital São Francisco Xavier
  • Hospital da Luz
  • CHUP, EPE - Hospital de Santo Antonio
  • Hospital Sanitas La Zarzuela
  • Hospital Universitario "Virgen de la Arrixaca"
  • Hospital del Mar
  • Hospital General Universitario Gregorio Marañón
  • Hospital Clínico Universitario San Carlos
  • Hospital Virgen de la Victoria
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitari i Politècnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Neladenoson bialanate (BAY1067197) (5 mg)

Neladenoson bialanate (BAY1067197) (10 mg)

Neladenoson bialanate (BAY1067197) (20 mg)

Neladenoson bialanate (BAY1067197) (30 mg)

Neladenoson bialanate (BAY1067197) (40 mg)

Placebo

Arm Description

Chronic heart failure with preserved ejection fraction

Chronic heart failure with preserved ejection fraction

Chronic heart failure with preserved ejection fraction

Chronic heart failure with preserved ejection fraction

Chronic heart failure with preserved ejection fraction

Chronic heart failure with preserved ejection fraction

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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.

Full Information

First Posted
March 15, 2017
Last Updated
July 4, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03098979
Brief Title
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Chronic Heart Failure, Heart Failure with Preserved Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neladenoson bialanate (BAY1067197) (5 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with preserved ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (10 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with preserved ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (20 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with preserved ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (30 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with preserved ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (40 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with preserved ejection fraction
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Chronic heart failure with preserved ejection fraction
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
5 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
10 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
20 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
30 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
40 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally once daily for 20 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
Description
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
Time Frame
Baseline, and up to 20 weeks of treatment
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity
Description
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".
Time Frame
Baseline, and up to 20 weeks of treatment
Title
Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks
Description
NT-proBNP = N-terminal pro-hormone b-type natriuretic peptide
Time Frame
Baseline, and up to 20 weeks of treatment
Title
Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks
Description
High sensitivity troponin T (hs-TNT) was measured
Time Frame
Baseline, and up to 20 weeks of treatment
Title
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
Description
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.
Time Frame
Baseline, and up to 20 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Louis Heart & Vascular, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
BryanLGH Medical Center East
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1045
Country
United States
Facility Name
Universitätsklinikum St. Pölten
City
St. Pölten
State/Province
Niederösterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Krankenhaus St. Josef Braunau
City
Braunau
State/Province
Oberösterreich
ZIP/Postal Code
5280
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz GmbH
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus Hietzing
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
Specialized Hospital for Actrive Treatm of Card - Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Medical Center Cardiohelp
City
Sofia
ZIP/Postal Code
1142
Country
Bulgaria
Facility Name
NMTH Tzar Boris III
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
MCOMH Preventsia-2000
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01069
Country
Germany
Facility Name
HELIOS Klinikum Erfurt GmbH
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum (CVK)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
KAT General Hospital of Athens
City
Kifisia / Athens
State/Province
Attica
ZIP/Postal Code
14561
Country
Greece
Facility Name
G. Gennimatas General State Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Chalkida
City
Chalkida
ZIP/Postal Code
34100
Country
Greece
Facility Name
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
City
Nea Ionia / Athens
ZIP/Postal Code
142 33
Country
Greece
Facility Name
Hippokration General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Asklipieion General Hospital of Voulas
City
Voula
ZIP/Postal Code
16673
Country
Greece
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital Mount Scopus
City
Jerusalem
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zrifin
ZIP/Postal Code
6093000
Country
Israel
Facility Name
AAS 3 Friuli Alto Medio Collin
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33038
Country
Italy
Facility Name
A.O.U. Sant'Andrea
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A.O. Ordine Mauriziano
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Facility Name
A.O.U. di Sassari
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
AUSL Toscana Sud-Est
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52040
Country
Italy
Facility Name
Chuno kosei Hospital
City
Seki
State/Province
Gifu
ZIP/Postal Code
501-3802
Country
Japan
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Shonan Fujisawa Tokushukai Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-0041
Country
Japan
Facility Name
R.I.A.C Naha City Hospital
City
Naha
State/Province
Okinawa
ZIP/Postal Code
902-8511
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-8522
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Minamino Cardiovascular Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
Okayama Rosai Hospital
City
Okayama
ZIP/Postal Code
702-8055
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Tokushima Prefectural Central Hospital
City
Tokushima
ZIP/Postal Code
770-8539
Country
Japan
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Szpital Zachodni w Grodzisku Mazowieckim
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Szpital Specjalistyczny im. J. Dietla
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
109 Szpital Wojskowy z przychodnia SPZOZ
City
Szczecin
ZIP/Postal Code
70-965
Country
Poland
Facility Name
Szpital Wolski im. dr Anny Gostynskiej SPZOZ
City
Warszawa
ZIP/Postal Code
02-211
Country
Poland
Facility Name
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
CHUC - Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
CHLO - Hospital São Francisco Xavier
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
CHUP, EPE - Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital Sanitas La Zarzuela
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
Hospital Universitario "Virgen de la Arrixaca"
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clínico Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31162568
Citation
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.
Results Reference
derived

Learn more about this trial

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

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