Heart Failure Clinical Trial

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

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

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

432

Study ID:

NCT05592275

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 126 Locations for this study

See Locations Near You

Valley Clinical Trials, Inc.
Covina California, 91723, United States More Info
Contact
626-598-4952
Fahed G Bitar
Principal Investigator
Valley Clinical Trials, Inc.
Northridge California, 91325, United States More Info
Mehrdad Ariani
Principal Investigator
Pasadena Clinical Research
Pasadena California, 91105, United States More Info
Fahed Bitar
Principal Investigator
Velocity Clinical Research, Coastal Heart Medical Group
Santa Ana California, 92704, United States More Info
Contact
714-290-5322
Anil Shah
Principal Investigator
Excel Medical Clinical Trials
Boca Raton Florida, 33434, United States More Info
Contact
561-756-8206
DAVID FUNT
Principal Investigator
South Florida Research Solutions - North Flamingo Road
Pembroke Pines Florida, 33028, United States More Info
Contact
954-986-3067
Julio Tallet
Principal Investigator
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States More Info
Frank W. Smart
Principal Investigator
Boston Medical Center
Boston Massachusetts, 02118, United States More Info
Contact
617-638-8060
David Pimentel
Principal Investigator
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Contact
313-916-6375
David Lanfear
Principal Investigator
University of North Carolina Medical Center
Chapel Hill North Carolina, 27514, United States More Info
Contact
919-843-5223
Kirkwood F Adams
Principal Investigator
PharmaTex Research
Amarillo Texas, 79109, United States
Baylor Scott & White Health-Advanced Heart and Lung Disease
Dallas Texas, 75246, United States More Info
Contact
2148206856
Cesar Yvan Guerrero-Miranda
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Alvin Chandra
Principal Investigator
University of Texas Medical Branch
Galveston Texas, 77555, United States More Info
Contact
409-772-1533
Wissam Khalife
Principal Investigator
West Houston Area Clinical Trial Consultants
Houston Texas, 77094, United States More Info
James Feldman
Principal Investigator
Texas Institute of Cardiology, PA
McKinney Texas, 75071, United States More Info
Contact
214-544-7555
Faisal Wahid
Principal Investigator
University of Wisconsin Hospitals and Clinics
Madison Wisconsin, 53792, United States More Info
Contact
608-263-0080
Aurangzeb Baber
Principal Investigator
Instituto de Investigaciones Clinicas Zarate
Zárate Buenos Aires, B2800, Argentina More Info
Contact
5493415597777
Marisa Liliana Vico
Principal Investigator
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire Buenos Air, C1027, Argentina More Info
Angela Maria Romero Zarante
Principal Investigator
Mautalen Salud e Investigación
Buenos Aires Ciudad Autónoma De Buenos Aires, C1128, Argentina More Info
Daniel Agustin Chirino Navarta
Principal Investigator
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires Ciudad Autónoma De Buenos Aires, C1425, Argentina More Info
Sonia Angelica Sassone
Principal Investigator
Investigaciones Medicas Imoba Srl
Balvanera Ciudad Autónoma De Buenos Aire, C1056, Argentina More Info
Contact
01144138877
Jose Maria Pedro Soler
Principal Investigator
Instituto Médico Río Cuarto
Río Cuarto Córdoba, 5800, Argentina More Info
Contact
5493584244340
Osvaldo Federico Magri
Principal Investigator
Hospital Provincial del Centenario
Rosario Santa Fe, 2002, Argentina More Info
Contact
543416003161
Martin Najenson
Principal Investigator
Instituto de Investigaciones Clinicas Rosario
Rosario Santa Fe, S2000, Argentina More Info
Jorgelina Mariana Sala
Principal Investigator
Sanatorio San Martin
Venado Tuerto Santa Fe, 2600, Argentina More Info
Oscar Gomez Vilamajo
Principal Investigator
Investigaciones Clínicas Tucumán
San Miguel de Tucuman Tucumán, 4000, Argentina More Info
Contact
543814210815
ALDO DANIEL PRADO
Principal Investigator
CEMEDIC
Buenos Aires , 1407, Argentina More Info
Contact
541146356624
Claudio R. Majul
Principal Investigator
Fundación Respirar
Buenos Aires , C1426, Argentina More Info
Contact
541170781548
Marina Paula Uhrig
Principal Investigator
Centro de Investigaciones Clinicas del Litoral
Santa Fe , 3000, Argentina More Info
Contact
5403424562779
Miguel Hominal
Principal Investigator
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe , 3000, Argentina More Info
Contact
543425112291
MARIA GUILLERMINA BEVILACQUA
Principal Investigator
Centro de Pesquisa Silvestre Santé
Rio Branco Acre, 69915, Brazil More Info
Odilson Silvestre
Principal Investigator
Universidade Federal de Goias
Goiania Goiás, 74605, Brazil More Info
Contact
556232698335
Aguinaldo F. Freitas
Principal Investigator
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
Curitiba Paraná, 80230, Brazil More Info
Contact
55413271570
Lidia Moura
Principal Investigator
Hospital de Clinicas de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90035, Brazil More Info
Adamastor Pereira
Principal Investigator
Centro de Pesquisa Clinica do Coracao
Acaraju Sergipe, 49055, Brazil More Info
Contact
5579999870794
FÁBIO SERRA SILVEIRA
Principal Investigator
Centro de Pesquisa Sao Lucas
Campinas São Paulo, 13034, Brazil More Info
Contact
551933438526
Aloisio Marchi Rocha
Principal Investigator
Instituto Do Coracao De Marilia
Marilia São Paulo, 17515, Brazil More Info
Contact
14981827485
Raphael Aparecido Barreto da Silva
Principal Investigator
CAPED Centro Avancado Pesquisa e Diagnostica
Ribeirao Preto São Paulo, 14026, Brazil More Info
Contact
551699118204
Pedro Vellosa Schwartzmann
Principal Investigator
Pesquisare Saude
Santo André São Paulo, 09080, Brazil More Info
Contact
1144273339
Wladimir Faustino Saporito
Principal Investigator
Hospital Santa Paula
Sao Paulo São Paulo, 04556, Brazil More Info
Otavio Gebara
Principal Investigator
Incor - Instituto do Coracao
Sao Paulo São Paulo, 05403, Brazil More Info
Contact
5511997081692
Edimar Alcides Bocchi
Principal Investigator
Instituto de Molestias Cardiovasculares de Tatui
Tatui São Paulo, 18270, Brazil More Info
Contact
1144273339
Wladimir Faustino Saporito
Principal Investigator
Integral Pesquisa e Ensino
Votuporanga São Paulo, 15501, Brazil More Info
Contact
5501734266090
Mauro Esteves Hernandes
Principal Investigator
Hospital São Lucas de Copacabana
Rio de Janeiro , 22061, Brazil More Info
Bruno de Souza Paolino
Principal Investigator
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro , 22281, Brazil More Info
Denilson Albuquerque
Principal Investigator
SMH Cardiology Clinical Trials
Surrey British Columbia, V3V 0, Canada More Info
Contact
17788749799
Dante Manyari
Principal Investigator
Private Practice - Dr. Saul Vizel
Cambridge Ontario, N1R 7, Canada More Info
Saul Vizel
Principal Investigator
PACE Cardiology
Newmarket Ontario, L3Y 2, Canada More Info
Yaariv Khaykin
Principal Investigator
North York Diagnostic and Cardiac Centre
North York Ontario, M6B 3, Canada More Info
Contact
4167830000
Subodh Verma
Principal Investigator
Oakville Trafalgar Memorial Hospital
Oakville Ontario, L6M 1, Canada More Info
Michael Heffernan
Principal Investigator
Heart Health Institute - Scarborough Office
Scarborough Ontario, M1B 4, Canada More Info
Contact
4162819499
Jason Burstein
Principal Investigator
Medicus MFC Research Clinic
Toronto Ontario, M4P 1, Canada More Info
Gordon Moe
Principal Investigator
Fadia El Boreky Medicine
Waterloo Ontario, N2J 1, Canada More Info
Contact
5195697592
Fadia El Boreky
Principal Investigator
CPS Research
Waterloo Ontario, N2T 0, Canada More Info
Amelia Yip
Principal Investigator
Centre Hospitalier Universite de Sherbrooke - Hôtel-Dieu Hospital
Sherbrooke Quebec, J1G 2, Canada More Info
Serge Lepage
Principal Investigator
Fakultní nemocnice Brno Bohunice
Brno Brno-město, 62500, Czechia More Info
Martin Radvan
Principal Investigator
Fakultni Nemocnice u sv. Anny v Brne
Brno Jihomoravský Kraj, 60200, Czechia More Info
Robert Prosecky
Principal Investigator
Vseobecna fakultni nemocnice v Praze
Praha 2 , 12808, Czechia More Info
Jan Belohlavek
Principal Investigator
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged Csongrád, 6720, Hungary More Info
Contact
3662545553
Albert Varga
Principal Investigator
Medifarma 98 Kft
Nyiregyhaza Nyíregyháza, 4400, Hungary More Info
Contact
06209530430
Zsolt Zilahi
Principal Investigator
Flor Ferenc Hospital of Pest County
Kistarcsa Pest, 2143, Hungary More Info
Contact
28507600
Robert J. Kirschner
Principal Investigator
Belvárosi Egészségház
Zalaegerszeg Zala, 8900, Hungary More Info
Contact
3692507500
Geza Lupkovics
Principal Investigator
Dél-Pesti Centrumkórház
Budapest , 1097, Hungary More Info
Contact
0036309343629
Andras R Vertes
Principal Investigator
Semmelweis University
Budapest , 1122, Hungary More Info
Contact
3614586840
Béla Merkely
Principal Investigator
Yitzhak Shamir Medical Center
Zerifin HaMerkaz, 60930, Israel More Info
Gil Moravsky
Principal Investigator
Rambam Health Care Campus
Haifa HaTsafon, 31096, Israel More Info
oren caspi
Principal Investigator
Sourasky Medical Center
Tel Aviv Tell Abīb, 64239, Israel More Info
Ben Sadeh
Principal Investigator
Hadassah Medical Center
Jerusalem Yerushalayim, 91120, Israel More Info
Offer Amir
Principal Investigator
Kasugai Municipal Hospital
Kasugai Aichi, 486-8, Japan More Info
Mitsutoshi Oguri
Principal Investigator
Japanese Red Cross Nagoya Daini Hospital
Nagoya Aichi, 466-8, Japan More Info
Hirohiko Suzuki
Principal Investigator
Saiseikai Futsukaichi Hospital
Chikushino Fukuoka, 818-8, Japan More Info
Contact
81929231551
Toshiaki Kadokami
Principal Investigator
Nakamura Cardiovascular Clinic
Itoshima Fukuoka, 819-1, Japan More Info
Yuichiro Nakamura
Principal Investigator
Gunma University Hospital
Maebashi Gunma, 371-8, Japan More Info
Masaru Obokata
Principal Investigator
National Hospital Organization Takasaki General Medical Centar
Takasaki Gunma, 370-0, Japan More Info
Contact
81273225901
Nobuaki Fukuda
Principal Investigator
Yokohama City University Medical Center
Yokohama Kanagawa, 232-0, Japan More Info
Kiyoshi Hibi
Principal Investigator
Yokohama Minami Kyosai Hospital
Yokohama Kanagawa, 236-0, Japan More Info
Makoto Suzuki
Principal Investigator
Kanagawa Cardiovascular and Respiratory Center
Yokohama Kanagawa, 236-0, Japan More Info
Kazuki Fukui
Principal Investigator
Minamino Cardiovascular Hospital
Hachioji Tokyo, 192-0, Japan More Info
Yoshiki Hata
Principal Investigator
Ome Municipal General Hospital
Ome Tokyo, 198-0, Japan More Info
Yuichi Ono
Principal Investigator
Yamanashi Prefectural Central Hospital
Kofu Yamanashi, 400-8, Japan More Info
Contact
0552537111
Ken Umetani
Principal Investigator
Harasanshin Hospital
Fukuoka , 812-0, Japan More Info
Toyokazu Uwatoku
Principal Investigator
Rakuwakai Otowa Hospital
Kyoto , 607-8, Japan More Info
Hirokazu Yokoi
Principal Investigator
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan More Info
Atsuyuki Watanabe
Principal Investigator
Sakurabashi Watanabe Hospital
Osaka , 530-0, Japan More Info
Kenshi Fujii
Principal Investigator
Yodogawa Christian Hospital
Osaka , 533-0, Japan More Info
Contact
81672203494
Hiroshi Takaishi
Principal Investigator
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Osaka , 540-0, Japan More Info
Contact
81669421331
Yasunori Ueda
Principal Investigator
Toyama Prefectural Central Hospital
Toyama , 930-0, Japan More Info
Contact
81764241531
Michiro Maruyama
Principal Investigator
NZOZ Centrum Medyczne KERmed
Bydgoszcz Kujawsko-pomorskie, 85-23, Poland More Info
Contact
48600249404
Tomasz Lugowski
Principal Investigator
INTERCOR
Bydgoszcz Kujawsko-pomorskie, 85-60, Poland More Info
Contact
48603127021
Grzegorz Grzesk
Principal Investigator
1 Wojskowy Szpital Kliniczny w Lublinie
Lublin Lubelskie, 20-04, Poland More Info
Grzegorz Sobieszek
Principal Investigator
CenterMed Lublin NZOZ
Lublin Lubelskie, 20-04, Poland More Info
Contact
48601651647
Grzegorz Drelich
Principal Investigator
Balsam Medica
Warsaw Mazowieckie, 01-24, Poland More Info
Marcin Grabowski
Principal Investigator
Private Practice - Dr. Ewa Mirek Bryniarska
Krakow Małopolskie, 30-08, Poland More Info
Ewa Mirek-Bryniarska
Principal Investigator
MEDICOME Centrum Badań Klinicznych Oświęcimskie
Oświęcim Małopolskie, 32-66, Poland More Info
Contact
48505121703
Witold Zmuda
Principal Investigator
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemysl Podkarpackie, 37-70, Poland More Info
Lukasz Wisniowski
Principal Investigator
Uniwersytecki Szpital Kliniczny w Białymstoku
Białystok Podlaskie, 15-54, Poland More Info
Anna Tomaszuk-Kazberuk
Principal Investigator
KLIMED Marek Klimkiewicz
Białystok Podlaskie, 15-70, Poland More Info
Contact
0048603157778
Marzena Ewa Ginel
Principal Investigator
IRMED Osrodek Badan Klinicznych
Piotrkow Trybunalski Łódzkie, 97-30, Poland More Info
Contact
48447890484
TOMASZ CIURUS
Principal Investigator
Provita Profamilia
Piotrkow Trybunalski Łódzkie, 97-30, Poland More Info
Contact
692050663
Ewa Kalecinska-Krystkiewicz
Principal Investigator
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital Wetera -T
Łódź Łódzkie, 90-54, Poland More Info
Malgorzata Lelonek
Principal Investigator
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Łódź Łódzkie, 93-51, Poland More Info
Grzegorz Piotrowski
Principal Investigator
CHUS - Hospital Clinico Universitario
Santiago de Compostela A Coruña [La Coruña], 15706, Spain More Info
Contact
340981955740
Jose Ramon Gonzalez-Juanatey
Principal Investigator
Hospital de Denia Marina Salud
Dénia Alicante, 03700, Spain More Info
ALFONSO VALLE
Principal Investigator
Hospital Universitario Reina Sofia
Cordoba Andalucía, 14004, Spain More Info
Juan Carlos Castillo Dominguez
Principal Investigator
Hospital Universitario Virgen de Valme
Sevilla Andalucía, 41014, Spain More Info
Antonio Reyes Dominguez
Principal Investigator
Hospital Germans Trias i Pujol
Badalona Barcelona [Barcelona], 08916, Spain More Info
Contact
934978915
Antoni Bayes Genis
Principal Investigator
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat Catalunya [Cataluña], 08907, Spain More Info
Contact
0034932607078
Cristina Enjuanes Grau
Principal Investigator
Hospital San Juan de la Cruz
Ubeda Jaén, 23400, Spain More Info
Contact
671560156
Juan Luis Bonilla Palomas
Principal Investigator
Hospital Universitario Ramón y Cajal
Madrid Madrid, Comunidad De, 28034, Spain More Info
Contact
34913368000
PAU LLACER IBORRA
Principal Investigator
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia Murcia, Región De, 30120, Spain More Info
Contact
34968369445
Domingo Pascual Figal
Principal Investigator
Hospital Universitario Virgen de la Victoria
Malaga Málaga, 29010, Spain More Info
Contact
620441434
Juan Jose Gomez Doblas
Principal Investigator
Hospital Clinico de Valencia
Valencia Valenciana, Comunitat, 46010, Spain More Info
Contact
34961973520
Julio Nunez Villota
Principal Investigator
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Juan Francisco Delgado
Principal Investigator
Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Yıldırım Bursa, 16310, Turkey More Info
Hasan ARI
Principal Investigator
Eskisehir Osmangazi University
Eskisehir Eskişehir, 26480, Turkey More Info
Yuksel Cavusoglu
Principal Investigator
Ege Universitesi Hastanesi
Bornova İzmir, 35100, Turkey More Info
Latife Kayikcioglu
Principal Investigator
Afyon Kocatepe Üniversitesi Tıp Fakültesi
Afyonkarahisar , 03200, Turkey More Info
Ersel Onrat
Principal Investigator
Ankara Etlik City Hospital
Ankara , 06170, Turkey More Info
Hakan Gullu
Principal Investigator
Trakya University
Edirne , 22030, Turkey More Info
Servet Altay
Principal Investigator
Dokuz Eylul Universitesi Hastanesi
İzmir , 35340, Turkey More Info
MEHMET BIRHAN YILMAZ
Principal Investigator
Kocaeli Üniversitesi
Kocaeli , 41380, Turkey More Info
Tayfun Sahin
Principal Investigator
Mersin University
Mersin , 33343, Turkey More Info
Turkay Ozcan
Principal Investigator
Wycombe General Hospital
High Wycombe Buckinghamshire, HP11 , United Kingdom More Info
Contact
01494425958
Mayooran Shanmuganathan
Principal Investigator
Raigmore Hospital
Inverness Highland, IV2 3, United Kingdom More Info
Stephen James Leslie
Principal Investigator
Northwick Park Hospital
Harrow London, City Of, HA1 3, United Kingdom More Info
Contact
02088692548
Hugh Bethell
Principal Investigator
Glasgow Royal Infirmary
Glasgow Scotland, G31 2, United Kingdom More Info
Contact
01412114833
Mark Petrie
Principal Investigator
Aintree University Hospital NHS Foundation Trust
Liverpool , L9 7A, United Kingdom More Info
Contact
01515292708
Prathap Kanagala
Principal Investigator
Wythenshawe Hospital
Manchester , M23 9, United Kingdom More Info
Chris Miller
Principal Investigator
Royal Berkshire Hospital
Reading , RG1 5, United Kingdom More Info
Charlie McKenna
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

432

Study ID:

NCT05592275

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.