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A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

Primary Purpose

Heart Failure, Heart Failure With Preserved Ejection Fraction

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3540378
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Prior chronic treatment, or prescription, with a loop diuretic (for example, furosemide, torsemide, bumetanide) for ≥30 days prior to the index event. Index event is defined as a recent hospitalization for HF requiring at least 2 doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring at least 2 doses of intravenous diuretics.
  • Chronic HF diagnosed for at least 3 months before V1 (screening).
  • Documented LVEF of ≥50% within 6 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT).

  • Had evidence of clinical HF syndrome consisting of

    • Hospitalization for HF within the past 2 weeks from randomization, for worsening heart failure (WHF) with intravascular volume overload (the index event), as determined by the investigator, based on appropriate supportive documentation at randomization, and defined by ≥2 of the following:
    • dyspnea
    • jugular venous distention
    • pitting edema in lower extremities (>1+)
    • ascites
    • pulmonary congestion on chest X-ray
    • pulmonary rales AND participant received treatment with IV diuretics.

OR

  • Treatment for an urgent visit outside of of being hospitalized with WHF and intravascular volume overload (the index visit) requiring treatment with IV diuretics (defined as ≥2 IV doses) such as in the outpatient setting/emergency room/observation unit/infusion clinic with a clinical response within the past 2 weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF defined by ≥2 of the following:

    • dyspnea
    • jugular venous distention
    • pitting edema in lower extremities (>1+)
    • ascites
    • pulmonary rales on lung examination.
  • NT-proBNP (>300 [sinus rhythm] or 900 picograms/milliliter (pg/mL) [atrial fibrillation or atrial flutter] OR brain natriuretic (BNP) (>100 [sinus rhythm] or 300 pg/mL [atrial fibrillation or atrial flutter]) at screening.

Note: The presence or absence of atrial fibrillation or atrial flutter to determine the appropriate cut-off for a given BNP or NT-proBNP sample should be evaluated using electrocardiogram (ECG) performed at screening prior to the collection of the BNP or NT-proBNP sample.

Exclusion Criteria

  • Prior documentation of low ventricle ejection fraction (LVEF) ≤45% in the past 12 months.
  • Have had acute coronary syndrome or percutaneous coronary intervention, coronary artery bypass graft, cardiac mechanical support implantation, within 3 months prior to day 2. (randomization), or any other cardiac surgery planned during the study.
  • Have had Left Ventricular assist device (LVAD) or cardiac transplantation or have cardiac transplantation planned during the study.
  • Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, known amyloid cardiomyopathy, or inherited cardiomyopathy.
  • Have severe chronic obstructive pulmonary disease (COPD) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
  • Uncorrected thyroid disease.

Sites / Locations

  • Pima HeartRecruiting
  • Valley Clinical Trials, Inc.Recruiting
  • Valley Clinical Trials, Inc.Recruiting
  • University of California Irvine Medical CenterRecruiting
  • Pasadena Clinical ResearchRecruiting
  • Velocity Clinical Research, Coastal Heart Medical GroupRecruiting
  • Excel Medical Clinical TrialsRecruiting
  • Infinite Clinical ResearchRecruiting
  • South Florida Research Solutions - North Flamingo RoadRecruiting
  • University Medical Center New Orleans
  • Boston Medical CenterRecruiting
  • Henry Ford HospitalRecruiting
  • University of North Carolina Medical CenterRecruiting
  • Abington Memorial HospitalRecruiting
  • PharmaTex ResearchRecruiting
  • Baylor Scott & White Health-Advanced Heart and Lung DiseaseRecruiting
  • UT Southwestern Medical CenterRecruiting
  • University of Texas Medical BranchRecruiting
  • West Houston Area Clinical Trial ConsultantsRecruiting
  • Texas Institute of Cardiology, PARecruiting
  • Instituto de Investigaciones Clinicas ZarateRecruiting
  • Centro de Investigaciones Metabólicas (CINME)Recruiting
  • Mautalen Salud e InvestigaciónRecruiting
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  • Investigaciones Medicas Imoba SrlRecruiting
  • Instituto Médico Río CuartoRecruiting
  • Instituto de Investigaciones Clinicas Rosario
  • Hospital Provincial del CentenarioRecruiting
  • Sanatorio San Martin
  • Investigaciones Clínicas TucumánRecruiting
  • CEMEDICRecruiting
  • Fundación RespirarRecruiting
  • Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
  • Clínica de Nefrología, Urología y Enfermedades CardiovascularesRecruiting
  • Centro de Investigaciones Clinicas del LitoralRecruiting
  • Universidade Federal de GoiasRecruiting
  • PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPRRecruiting
  • Centro de Pesquisa Clinica do CoracaoRecruiting
  • Instituto de Pesquisa clinica de CampinasRecruiting
  • Centro de Pesquisa Sao LucasRecruiting
  • Instituto Do Coracao De MariliaRecruiting
  • CAPED Centro Avancado Pesquisa e DiagnosticaRecruiting
  • Pesquisare SaudeRecruiting
  • Incor - Instituto do CoracaoRecruiting
  • Instituto de Molestias Cardiovasculares de TatuiRecruiting
  • Hospital São Lucas de CopacabanaRecruiting
  • Misericordia Community HospitalRecruiting
  • SMH Cardiology Clinical TrialsRecruiting
  • Cambridge Cardiac Care Centre
  • Private Practice - Dr. Saul Vizel
  • North York Diagnostic and Cardiac CentreRecruiting
  • Oakville Trafalgar Memorial Hospital
  • Heart Health Institute - Scarborough OfficeRecruiting
  • Fadia El Boreky MedicineRecruiting
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai KözpontRecruiting
  • Medifarma 98 KftRecruiting
  • Flor Ferenc Hospital of Pest CountyRecruiting
  • Belvárosi EgészségházRecruiting
  • Dél-Pesti CentrumkórházRecruiting
  • Semmelweis UniversityRecruiting
  • Saiseikai Futsukaichi HospitalRecruiting
  • Nakamura Cardiovascular ClinicRecruiting
  • National Hospital Organization Takasaki General Medical CentarRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Yokohama Minami Kyosai HospitalRecruiting
  • Kanagawa Cardiovascular and Respiratory CenterRecruiting
  • Minamino Cardiovascular HospitalRecruiting
  • Ome Municipal General HospitalRecruiting
  • Yamanashi Prefectural Central HospitalRecruiting
  • Harasanshin HospitalRecruiting
  • Rakuwakai Otowa HospitalRecruiting
  • National Hospital Organization Okayama Medical CenterRecruiting
  • Sakurabashi Watanabe HospitalRecruiting
  • Yodogawa Christian HospitalRecruiting
  • National Hospital Organization - Osaka National Hospital - Institute For Clinical ResearchRecruiting
  • Toyama Prefectural Central HospitalRecruiting
  • NZOZ Centrum Medyczne KERmedRecruiting
  • INTERCORRecruiting
  • CenterMed Lublin NZOZRecruiting
  • Private Practice - Dr. Ewa Mirek BryniarskaRecruiting
  • MEDICOME Centrum Badań Klinicznych OświęcimskieRecruiting
  • KLIMED Marek KlimkiewiczRecruiting
  • Szpital Św. Wincentego a Paulo Spółka
  • IRMED Osrodek Badan KlinicznychRecruiting
  • Provita ProfamiliaRecruiting
  • CHUS - Hospital Clinico UniversitarioRecruiting
  • Hospital Universitario Virgen de ValmeRecruiting
  • Hospital Germans Trias i PujolRecruiting
  • Hospital Universitari de BellvitgeRecruiting
  • Hospital San Juan de la CruzRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Clinico de ValenciaRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Wycombe General HospitalRecruiting
  • Raigmore Hospital
  • Northwick Park HospitalRecruiting
  • Glasgow Royal InfirmaryRecruiting
  • Aintree University Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LY3540378 Dose 1

LY3540378 Dose 2

LY3540378 Dose 3

Placebo

Arm Description

Participants will receive LY3540378 subcutaneously (SC).

Participants will receive LY3540378 SC.

Participants will receive LY3540378 SC.

Participants will be given placebo SC.

Outcomes

Primary Outcome Measures

Change from Baseline in Left Atrial Reservoir Strain (LARS)

Secondary Outcome Measures

Change from Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Change from Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI)
Change from Baseline Left Atrial End-Systolic Volume Index (LAESVI)
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
eGFR calculated by creatinine and cystatin C
Change from Baseline in Serum Creatinine
Change from Baseline in cystatin-C

Full Information

First Posted
October 20, 2022
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05592275
Brief Title
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
November 27, 2024 (Anticipated)
Study Completion Date
January 8, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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

5. Study Description

Brief Summary
The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3540378 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive LY3540378 subcutaneously (SC).
Arm Title
LY3540378 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive LY3540378 SC.
Arm Title
LY3540378 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive LY3540378 SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be given placebo SC.
Intervention Type
Drug
Intervention Name(s)
LY3540378
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in Left Atrial Reservoir Strain (LARS)
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change from Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Time Frame
Baseline, Week 26
Title
Change from Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI)
Time Frame
Baseline, Week 26
Title
Change from Baseline Left Atrial End-Systolic Volume Index (LAESVI)
Time Frame
Baseline, Week 26
Title
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Description
eGFR calculated by creatinine and cystatin C
Time Frame
Baseline, Week 26
Title
Change from Baseline in Serum Creatinine
Time Frame
Baseline, Week 26
Title
Change from Baseline in cystatin-C
Time Frame
Baseline, Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prior chronic treatment, or prescription, with a loop diuretic (for example, furosemide, torsemide, bumetanide) for ≥30 days prior to the index event. Medical records, discharge notes and physician referral letters may serve as documentation for prior chronic treatment with a loop diuretic. Experienced an index event, defined as a recent hospitalization for HF requiring ≥2 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥2 bolus doses of intravenous diuretics. Chronic HF diagnosed for at least 3 months before V1 (screening) Documented LVEF of ≥50% within 12 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT). Evidence of documentation of LVEF of ≥50% may also include participant medical records, discharge notes or a referral letter from the participant's physician or referring physician that details the participant's medical history. Had evidence of clinical HF syndrome consisting of Hospitalization for worsening heart failure (WHF) with intravascular volume overload (the index event), as determined by the investigator, based on appropriate supportive documentation at randomization, and defined by ≥2 of the following: dyspnea jugular venous distention pitting edema in lower extremities (>1+) ascites pulmonary congestion on chest X-ray pulmonary rales AND participant received treatment with IV diuretics. OR Treatment for an urgent visit outside of of being hospitalized with WHF and intravascular volume overload (the index visit) requiring treatment with IV diuretics (defined as ≥2 IV doses) such as in the outpatient setting/emergency room/observation unit/infusion clinic with a clinical response within the past 2 weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF defined by ≥2 of the following: dyspnea jugular venous distention pitting edema in lower extremities (>1+) ascites pulmonary rales on lung examination. NT-proBNP (>300 [sinus rhythm] or 900 picograms/milliliter (pg/mL) [atrial fibrillation or atrial flutter] OR brain natriuretic (BNP) (>100 [sinus rhythm] or 300 pg/mL [atrial fibrillation or atrial flutter]) at screening. Note: The presence or absence of atrial fibrillation or atrial flutter to determine the appropriate cut-off for a given BNP or NT-proBNP sample should be evaluated using electrocardiogram (ECG) performed at screening prior to the collection of the BNP or NT-proBNP sample. Exclusion Criteria Prior documentation of low ventricle ejection fraction (LVEF) ≤45% in the past 12 months. Have had acute coronary syndrome or percutaneous coronary intervention, coronary artery bypass graft, cardiac mechanical support implantation, within 3 months prior to day 2. (randomization), or any other cardiac surgery planned during the study. Have had Left Ventricular assist device (LVAD) or cardiac transplantation or have cardiac transplantation planned during the study. Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, known amyloid cardiomyopathy, or inherited cardiomyopathy. Have severe chronic obstructive pulmonary disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary. Uncorrected thyroid disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Pima Heart
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
5203149254
First Name & Middle Initial & Last Name & Degree
Nader Nader Makki
Facility Name
Valley Clinical Trials, Inc.
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
626-598-4952
First Name & Middle Initial & Last Name & Degree
Fahed G Bitar
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehrdad Ariani
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
7144566699
First Name & Middle Initial & Last Name & Degree
Andy Yen-Tang Lee
Facility Name
Pasadena Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
626-598-4952
First Name & Middle Initial & Last Name & Degree
Fahed G Bitar
Facility Name
Velocity Clinical Research, Coastal Heart Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
714-290-5322
First Name & Middle Initial & Last Name & Degree
Anil Shah
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-756-8206
First Name & Middle Initial & Last Name & Degree
Seth J. Baum
Facility Name
Infinite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
7866313674
First Name & Middle Initial & Last Name & Degree
Jose Enrique Escalante
Facility Name
South Florida Research Solutions - North Flamingo Road
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-986-3067
First Name & Middle Initial & Last Name & Degree
Julio Tallet
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank W. Smart
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-638-8060
First Name & Middle Initial & Last Name & Degree
David Pimentel
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
313-916-6375
First Name & Middle Initial & Last Name & Degree
David Lanfear
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
919-843-5223
First Name & Middle Initial & Last Name & Degree
Kirkwood F Adams
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Haas
Facility Name
PharmaTex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
806-355-2581
First Name & Middle Initial & Last Name & Degree
David Brabham
Facility Name
Baylor Scott & White Health-Advanced Heart and Lung Disease
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2148206856
First Name & Middle Initial & Last Name & Degree
Cesar Yvan Guerrero-Miranda
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvin Chandra
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
409-772-1533
First Name & Middle Initial & Last Name & Degree
Wissam Khalife
Facility Name
West Houston Area Clinical Trial Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
832-431-3587
First Name & Middle Initial & Last Name & Degree
James Feldman
Facility Name
Texas Institute of Cardiology, PA
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-544-7555
First Name & Middle Initial & Last Name & Degree
Faisal Wahid
Facility Name
Instituto de Investigaciones Clinicas Zarate
City
Zárate
State/Province
Buenos Aires
ZIP/Postal Code
B2800DGH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5493415597777
First Name & Middle Initial & Last Name & Degree
Marisa Liliana Vico
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Air
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541152364056
First Name & Middle Initial & Last Name & Degree
Angela Maria Romero Zarante
Facility Name
Mautalen Salud e Investigación
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Agustin Chirino Navarta
Facility Name
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
City
Ciudad Autonoma de Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Angelica Sassone
Facility Name
Investigaciones Medicas Imoba Srl
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1179AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
01144138877
First Name & Middle Initial & Last Name & Degree
Jose Maria Pedro Soler
Facility Name
Instituto Médico Río Cuarto
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
5800
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5493584244340
First Name & Middle Initial & Last Name & Degree
Osvaldo Federico Magri
Facility Name
Instituto de Investigaciones Clinicas Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CVD
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorgelina Mariana Sala
Facility Name
Hospital Provincial del Centenario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
543416003161
First Name & Middle Initial & Last Name & Degree
Martin Najenson
Facility Name
Sanatorio San Martin
City
Venado Tuerto
State/Province
Santa Fe
ZIP/Postal Code
2600
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Gomez Vilamajo
Facility Name
Investigaciones Clínicas Tucumán
City
San Miguel de Tucuman
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
543814210815
First Name & Middle Initial & Last Name & Degree
ALDO DANIEL PRADO
Facility Name
CEMEDIC
City
Buenos Aires
ZIP/Postal Code
1407
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541146356624
First Name & Middle Initial & Last Name & Degree
Claudio R. Majul
Facility Name
Fundación Respirar
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541170781548
First Name & Middle Initial & Last Name & Degree
Marina Paula Uhrig
Facility Name
Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
City
Formosa
ZIP/Postal Code
3600
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
03704555398
First Name & Middle Initial & Last Name & Degree
Liza Maria Marcela Wenetz
Facility Name
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
543425112291
First Name & Middle Initial & Last Name & Degree
MARIA GUILLERMINA BEVILACQUA
Facility Name
Centro de Investigaciones Clinicas del Litoral
City
Santa Fe
ZIP/Postal Code
S3000FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5403424562779
First Name & Middle Initial & Last Name & Degree
Miguel Hominal
Facility Name
Universidade Federal de Goias
City
Goiania
State/Province
Goiás
ZIP/Postal Code
74605-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
556232698335
First Name & Middle Initial & Last Name & Degree
Aguinaldo F. Freitas
Facility Name
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80230-130
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
55413271570
First Name & Middle Initial & Last Name & Degree
Jose Augusto Ribas Fortes
Facility Name
Centro de Pesquisa Clinica do Coracao
City
Acaraju
State/Province
Sergipe
ZIP/Postal Code
49055-530
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
5579999870794
First Name & Middle Initial & Last Name & Degree
FÁBIO SERRA SILVEIRA
Facility Name
Instituto de Pesquisa clinica de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
1932670023
First Name & Middle Initial & Last Name & Degree
Jose Francisco Kerr Saraiva
Facility Name
Centro de Pesquisa Sao Lucas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-803
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551933438526
First Name & Middle Initial & Last Name & Degree
Aloisio Marchi Rocha
Facility Name
Instituto Do Coracao De Marilia
City
Marilia
State/Province
São Paulo
ZIP/Postal Code
17515-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
14981827485
First Name & Middle Initial & Last Name & Degree
Raphael Aparecido Barreto da Silva
Facility Name
CAPED Centro Avancado Pesquisa e Diagnostica
City
Ribeirao Preto
State/Province
São Paulo
ZIP/Postal Code
14026-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551699118204
First Name & Middle Initial & Last Name & Degree
Pedro Vellosa Schwartzmann
Facility Name
Pesquisare Saude
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09080-110
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
1144273339
First Name & Middle Initial & Last Name & Degree
Wladimir Faustino Saporito
Facility Name
Incor - Instituto do Coracao
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
5511997081692
First Name & Middle Initial & Last Name & Degree
Edimar Alcides Bocchi
Facility Name
Instituto de Molestias Cardiovasculares de Tatui
City
Tatui
State/Province
São Paulo
ZIP/Postal Code
18270-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
1144273339
First Name & Middle Initial & Last Name & Degree
Wladimir Faustino Saporito
Facility Name
Hospital São Lucas de Copacabana
City
Rio de Janeiro
ZIP/Postal Code
22061-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno de Souza Paolino
Facility Name
Misericordia Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 4H5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
17807352255
First Name & Middle Initial & Last Name & Degree
Marcelo C Shibata
Facility Name
SMH Cardiology Clinical Trials
City
Surrey
State/Province
British Co
ZIP/Postal Code
V3V 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
17788749799
First Name & Middle Initial & Last Name & Degree
Dante Manyari
Facility Name
Cambridge Cardiac Care Centre
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Shekhar Pandey
Facility Name
Private Practice - Dr. Saul Vizel
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7R1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saul Vizel
Facility Name
North York Diagnostic and Cardiac Centre
City
North York
State/Province
Ontario
ZIP/Postal Code
M6B 3H7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4167830000
First Name & Middle Initial & Last Name & Degree
Subodh Verma
Facility Name
Oakville Trafalgar Memorial Hospital
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 1M1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Heffernan
Facility Name
Heart Health Institute - Scarborough Office
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4162819499
First Name & Middle Initial & Last Name & Degree
Jason Burstein
Facility Name
Fadia El Boreky Medicine
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
5195697592
First Name & Middle Initial & Last Name & Degree
Fadia El Boreky
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
3662545553
First Name & Middle Initial & Last Name & Degree
Albert Varga
Facility Name
Medifarma 98 Kft
City
Nyiregyhaza
State/Province
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
06209530430
First Name & Middle Initial & Last Name & Degree
Zsolt Zilahi
Facility Name
Flor Ferenc Hospital of Pest County
City
Kistarcsa
State/Province
Pest
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
28507600
First Name & Middle Initial & Last Name & Degree
Robert J. Kirschner
Facility Name
Belvárosi Egészségház
City
Zalaegerszeg
State/Province
Zala
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
3692507500
First Name & Middle Initial & Last Name & Degree
Geza Lupkovics
Facility Name
Dél-Pesti Centrumkórház
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
0036309343629
First Name & Middle Initial & Last Name & Degree
Andras R Vertes
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1536
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
3614586840
First Name & Middle Initial & Last Name & Degree
Béla Merkely
Facility Name
Saiseikai Futsukaichi Hospital
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8516
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81929231551
First Name & Middle Initial & Last Name & Degree
Toshiaki Kadokami
Facility Name
Nakamura Cardiovascular Clinic
City
Itoshima
State/Province
Fukuoka
ZIP/Postal Code
819-1104
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichiro Nakamura
Facility Name
National Hospital Organization Takasaki General Medical Centar
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81273225901
First Name & Middle Initial & Last Name & Degree
Nobuaki Fukuda
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Hibi
Facility Name
Yokohama Minami Kyosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0037
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makoto Suzuki
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuki Fukui
Facility Name
Minamino Cardiovascular Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiki Hata
Facility Name
Ome Municipal General Hospital
City
Ome
State/Province
Tokyo
ZIP/Postal Code
198-0042
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Ono
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0552537111
First Name & Middle Initial & Last Name & Degree
Ken Umetani
Facility Name
Harasanshin Hospital
City
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toyokazu Uwatoku
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirokazu Yokoi
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1154
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsuyuki Watanabe
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenshi Fujii
Facility Name
Yodogawa Christian Hospital
City
Osaka
ZIP/Postal Code
533-0024
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81672203494
First Name & Middle Initial & Last Name & Degree
Hiroshi Takaishi
Facility Name
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81669421331
First Name & Middle Initial & Last Name & Degree
Yasunori Ueda
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-0975
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81764241531
First Name & Middle Initial & Last Name & Degree
Michiro Maruyama
Facility Name
NZOZ Centrum Medyczne KERmed
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-231
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48600249404
First Name & Middle Initial & Last Name & Degree
Tomasz Lugowski
Facility Name
INTERCOR
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-605
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48603127021
First Name & Middle Initial & Last Name & Degree
Grzegorz Grzesk
Facility Name
CenterMed Lublin NZOZ
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-044
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48601651647
First Name & Middle Initial & Last Name & Degree
Grzegorz Drelich
Facility Name
Private Practice - Dr. Ewa Mirek Bryniarska
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
30-082
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Mirek-Bryniarska
Facility Name
MEDICOME Centrum Badań Klinicznych Oświęcimskie
City
Oświęcim
State/Province
Małopolskie
ZIP/Postal Code
32-660
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48505121703
First Name & Middle Initial & Last Name & Degree
Witold Zmuda
Facility Name
KLIMED Marek Klimkiewicz
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-704
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
0048603157778
First Name & Middle Initial & Last Name & Degree
Marzena Ewa Ginel
Facility Name
Szpital Św. Wincentego a Paulo Spółka
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-348
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
48601644482
First Name & Middle Initial & Last Name & Degree
Pawel Miekus
Facility Name
IRMED Osrodek Badan Klinicznych
City
Piotrkow Trybunalski
State/Province
Łódzkie
ZIP/Postal Code
97-300
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48447890484
First Name & Middle Initial & Last Name & Degree
TOMASZ CIURUS
Facility Name
Provita Profamilia
City
Piotrkow Trybunalski
State/Province
Łódzkie
ZIP/Postal Code
97-300
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
692050663
First Name & Middle Initial & Last Name & Degree
Ewa Kalecinska-Krystkiewicz
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
340981955740
First Name & Middle Initial & Last Name & Degree
Jose Ramon Gonzalez-Juanatey
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Reyes Dominguez
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
934978915
First Name & Middle Initial & Last Name & Degree
Antoni Bayes Genis
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
0034932607078
First Name & Middle Initial & Last Name & Degree
Cristina Enjuanes Grau
Facility Name
Hospital San Juan de la Cruz
City
Ubeda
State/Province
Jaén
ZIP/Postal Code
23400
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
671560156
First Name & Middle Initial & Last Name & Degree
Juan Luis Bonilla Palomas
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34913368000
First Name & Middle Initial & Last Name & Degree
PAU LLACER IBORRA
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
El Palmar, Murcia
State/Province
Murcia, Región De
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34968369445
First Name & Middle Initial & Last Name & Degree
Domingo Pascual Figal
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
620441434
First Name & Middle Initial & Last Name & Degree
Juan Jose Gomez Doblas
Facility Name
Hospital Clinico de Valencia
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34961973520
First Name & Middle Initial & Last Name & Degree
Julio Nunez Villota
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Francisco Delgado
Facility Name
Wycombe General Hospital
City
High Wycombe
State/Province
Buckinghamshire
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
01494425958
First Name & Middle Initial & Last Name & Degree
Mayooran Shanmuganathan
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Highland
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen James Leslie
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
London, City Of
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
02088692548
First Name & Middle Initial & Last Name & Degree
Hugh Bethell
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
01412114833
First Name & Middle Initial & Last Name & Degree
Mark Petrie
Facility Name
Aintree University Hospital NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
01515292708
First Name & Middle Initial & Last Name & Degree
Prathap Kanagala

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/366076
Description
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

Learn more about this trial

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

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