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

February 29, 2024 updated by: Eli Lilly and Company

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

432

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Fundacion Respirar
        • Contact:
          • Phone Number: 541170781548
        • Principal Investigator:
          • Marina Paula Uhrig
      • Buenos Aires, Argentina, 1407
        • Recruiting
        • CEMEDIC
        • Contact:
          • Phone Number: 541146356624
        • Principal Investigator:
          • Claudio R. Majul
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Centro de Investigaciones Clinicas del Litoral
        • Contact:
          • Phone Number: 5403424562779
        • Principal Investigator:
          • Miguel Hominal
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
        • Contact:
          • Phone Number: 543425112291
        • Principal Investigator:
          • MARIA GUILLERMINA BEVILACQUA
    • Buenos Air
      • Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina, C1027AAP
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Principal Investigator:
          • Angela Maria Romero Zarante
    • Buenos Aires
      • Zárate, Buenos Aires, Argentina, B2800DGH
        • Recruiting
        • Instituto de Investigaciones Clinicas Zarate
        • Contact:
          • Phone Number: 5493415597777
        • Principal Investigator:
          • Marisa Liliana Vico
    • Ciudad Autónoma De Buenos Aire
      • Balvanera, Ciudad Autónoma De Buenos Aire, Argentina, C1056ABH
        • Recruiting
        • Investigaciones Medicas Imoba Srl
        • Contact:
          • Phone Number: 01144138877
        • Principal Investigator:
          • Jose Maria Pedro Soler
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF
        • Recruiting
        • Mautalen Salud e investigación
        • Principal Investigator:
          • Daniel Agustin Chirino Navarta
      • Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • Centro Médico Dra. Laura Maffei- Investigación Clinica Aplicada
        • Principal Investigator:
          • Sonia Angelica Sassone
    • Córdoba
      • Río Cuarto, Córdoba, Argentina, 5800
        • Recruiting
        • Instituto Medico Rio Cuarto
        • Contact:
          • Phone Number: 5493584244340
        • Principal Investigator:
          • Osvaldo Federico Magri
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CVD
        • Recruiting
        • Instituto de Investigaciones Clinicas Rosario
        • Principal Investigator:
          • Jorgelina Mariana Sala
      • Rosario, Santa Fe, Argentina, 2002
        • Recruiting
        • Hospital Provincial del Centenario
        • Contact:
          • Phone Number: 543416003161
        • Principal Investigator:
          • Martin Najenson
      • Venado Tuerto, Santa Fe, Argentina, 2600
        • Recruiting
        • Sanatorio San Martin
        • Principal Investigator:
          • Oscar Gomez Vilamajo
    • Tucumán
      • San Miguel de Tucuman, Tucumán, Argentina, 4000
        • Recruiting
        • Investigaciones Clinicas Tucuman
        • Principal Investigator:
          • ALDO DANIEL PRADO
        • Contact:
          • Phone Number: 543814210815
  • Brazil
      • Rio de Janeiro, Brazil, 22061-080
        • Recruiting
        • Hospital São Lucas de Copacabana
        • Principal Investigator:
          • Bruno de Souza Paolino
      • Rio de Janeiro, Brazil, 22281-100
        • Not yet recruiting
        • Instituto D'Or Pesquisa e Ensino
        • Principal Investigator:
          • Denilson Albuquerque
    • Acre
      • Rio Branco, Acre, Brazil, 69915-030
        • Not yet recruiting
        • Centro de Pesquisa Silvestre Santé
        • Principal Investigator:
          • Odilson Silvestre
    • Goiás
      • Goiania, Goiás, Brazil, 74605-020
        • Recruiting
        • Universidade Federal de Goias
        • Contact:
          • Phone Number: 556232698335
        • Principal Investigator:
          • Aguinaldo F. Freitas
    • Paraná
      • Curitiba, Paraná, Brazil, 80230-130
        • Recruiting
        • PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
        • Contact:
          • Phone Number: 55413271570
        • Principal Investigator:
          • Lidia Moura
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Not yet recruiting
        • Hospital de Clínicas de Porto Alegre
        • Principal Investigator:
          • Adamastor Pereira
    • Sergipe
      • Acaraju, Sergipe, Brazil, 49055-530
        • Recruiting
        • Centro de Pesquisa Clinica do Coracao
        • Contact:
          • Phone Number: 5579999870794
        • Principal Investigator:
          • FÁBIO SERRA SILVEIRA
    • São Paulo
      • Campinas, São Paulo, Brazil, 13034-685
        • Recruiting
        • Centro de Pesquisa Sao Lucas
        • Contact:
          • Phone Number: 551933438526
        • Principal Investigator:
          • Aloisio Marchi Rocha
      • Campinas, São Paulo, Brazil, 13060-080
        • Recruiting
        • Instituto de Pesquisa Clínica de Campinas
        • Contact:
          • Phone Number: 1932670023
        • Principal Investigator:
          • Jose Francisco Kerr Saraiva
      • Marilia, São Paulo, Brazil, 17515-000
        • Recruiting
        • Instituto do Coracao de Marília
        • Contact:
          • Phone Number: 14981827485
        • Principal Investigator:
          • Raphael Aparecido Barreto da Silva
      • Ribeirao Preto, São Paulo, Brazil, 14026-900
        • Recruiting
        • CAPED Centro Avancado Pesquisa e Diagnostica
        • Contact:
          • Phone Number: 551699118204
        • Principal Investigator:
          • Pedro Vellosa Schwartzmann
      • Santo André, São Paulo, Brazil, 09080-110
        • Recruiting
        • Pesquisare Saude
        • Contact:
          • Phone Number: 1144273339
        • Principal Investigator:
          • Wladimir Faustino Saporito
      • Sao Paulo, São Paulo, Brazil, 04556-100
        • Recruiting
        • Hospital Santa Paula
        • Principal Investigator:
          • Otavio Gebara
      • Sao Paulo, São Paulo, Brazil, 05403-900
        • Recruiting
        • Incor - Instituto do Coracao
        • Contact:
          • Phone Number: 5511997081692
        • Principal Investigator:
          • Edimar Alcides Bocchi
      • Tatui, São Paulo, Brazil, 18270-170
        • Recruiting
        • Instituto de Molestias Cardiovasculares de Tatui
        • Contact:
          • Phone Number: 1144273339
        • Principal Investigator:
          • Wladimir Faustino Saporito
      • Votuporanga, São Paulo, Brazil, 15501-405
        • Not yet recruiting
        • Integral Pesquisa e Ensino
        • Contact:
          • Phone Number: 5501734266090
        • Principal Investigator:
          • Mauro Esteves Hernandes
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Recruiting
        • SMH Cardiology Clinical Trials
        • Contact:
          • Phone Number: 17788749799
        • Principal Investigator:
          • Dante Manyari
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7R1
        • Recruiting
        • Private Practice - Dr. Saul Vizel
        • Principal Investigator:
          • Saul Vizel
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • North York Diagnostic and Cardiac Centre
        • Contact:
          • Phone Number: 4167830000
        • Principal Investigator:
          • Subodh Verma
      • Oakville, Ontario, Canada, L6M 1M1
        • Recruiting
        • Oakville Trafalgar Memorial Hospital
        • Principal Investigator:
          • Michael Heffernan
      • Scarborough, Ontario, Canada, M1B 4Z8
        • Recruiting
        • Heart Health Institute - Scarborough Office
        • Contact:
          • Phone Number: 4162819499
        • Principal Investigator:
          • Jason Burstein
      • Waterloo, Ontario, Canada, N2J 1C4
        • Recruiting
        • Fadia El Boreky Medicine
        • Contact:
          • Phone Number: 5195697592
        • Principal Investigator:
          • Fadia El Boreky
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Not yet recruiting
        • Centre Hospitalier Universite de Sherbrooke - Hôtel-Dieu Hospital
        • Principal Investigator:
          • Serge Lepage
  • Hungary
      • Budapest, Hungary, 1097
        • Recruiting
        • Dél-Pesti Centrumkórház
        • Contact:
          • Phone Number: 0036309343629
        • Principal Investigator:
          • Andras R Vertes
      • Budapest, Hungary, 1122
        • Recruiting
        • Semmelweis University
        • Contact:
          • Phone Number: 3614586840
        • Principal Investigator:
          • Béla Merkely
    • Csongrád
      • Szeged, Csongrád, Hungary, 6720
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
        • Contact:
          • Phone Number: 3662545553
        • Principal Investigator:
          • Albert Varga
    • Nyíregyháza
      • Nyiregyhaza, Nyíregyháza, Hungary, 4400
        • Recruiting
        • Medifarma 98 Kft
        • Contact:
          • Phone Number: 06209530430
        • Principal Investigator:
          • Zsolt Zilahi
    • Pest
      • Kistarcsa, Pest, Hungary, 2143
        • Recruiting
        • Flor Ferenc Hospital of Pest County
        • Contact:
          • Phone Number: 28507600
        • Principal Investigator:
          • Robert J. Kirschner
    • Zala
      • Zalaegerszeg, Zala, Hungary, 8900
        • Recruiting
        • Belvárosi Egészségház
        • Contact:
          • Phone Number: 3692507500
        • Principal Investigator:
          • Geza Lupkovics
  • Israel
    • HaMerkaz
      • Zerifin, HaMerkaz, Israel, 609300
        • Not yet recruiting
        • Yitzhak Shamir Medical Center
        • Principal Investigator:
          • Gil Moravsky
    • HaTsafon
      • Haifa, HaTsafon, Israel, 3109601
        • Not yet recruiting
        • Rambam Health Care Campus
        • Principal Investigator:
          • oren caspi
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Not yet recruiting
        • Sourasky Medical Center
        • Principal Investigator:
          • Ben Sadeh
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9112001
        • Not yet recruiting
        • Hadassah Medical Center
        • Principal Investigator:
          • Offer Amir
  • Japan
      • Fukuoka, Japan, 812-0033
        • Recruiting
        • Harasanshin Hospital
        • Principal Investigator:
          • Toyokazu Uwatoku
      • Kyoto, Japan, 607-8062
        • Recruiting
        • Rakuwakai Otowa Hospital
        • Principal Investigator:
          • Hirokazu Yokoi
      • Okayama, Japan, 701-1154
        • Recruiting
        • National Hospital Organization Okayama Medical Center
        • Principal Investigator:
          • Atsuyuki Watanabe
      • Osaka, Japan, 540-0006
        • Recruiting
        • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
        • Contact:
          • Phone Number: 81669421331
        • Principal Investigator:
          • Yasunori Ueda
      • Osaka, Japan, 530-0001
        • Recruiting
        • Sakurabashi Watanabe Hospital
        • Principal Investigator:
          • Kenshi Fujii
      • Osaka, Japan, 533-0024
        • Recruiting
        • Yodogawa Christian Hospital
        • Contact:
          • Phone Number: 81672203494
        • Principal Investigator:
          • Hiroshi Takaishi
      • Toyama, Japan, 930-0975
        • Recruiting
        • Toyama Prefectural Central Hospital
        • Contact:
          • Phone Number: 81764241531
        • Principal Investigator:
          • Michiro Maruyama
    • Aichi
      • Kasugai, Aichi, Japan, 486-8510
        • Recruiting
        • Kasugai Municipal Hospital
        • Principal Investigator:
          • Mitsutoshi Oguri
      • Nagoya, Aichi, Japan, 466-8650
        • Recruiting
        • Japanese Red Cross Nagoya Daini Hospital
        • Principal Investigator:
          • Hirohiko Suzuki
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-8516
        • Recruiting
        • Saiseikai Futsukaichi Hospital
        • Contact:
          • Phone Number: 81929231551
        • Principal Investigator:
          • Toshiaki Kadokami
      • Itoshima, Fukuoka, Japan, 819-1104
        • Recruiting
        • Nakamura Cardiovascular Clinic
        • Principal Investigator:
          • Yuichiro Nakamura
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Not yet recruiting
        • Gunma University Hospital
        • Principal Investigator:
          • Masaru Obokata
      • Takasaki, Gunma, Japan, 370-0829
        • Recruiting
        • National Hospital Organization Takasaki General Medical Centar
        • Contact:
          • Phone Number: 81273225901
        • Principal Investigator:
          • Nobuaki Fukuda
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
        • Principal Investigator:
          • Kiyoshi Hibi
      • Yokohama, Kanagawa, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular And Respiratory Center
        • Principal Investigator:
          • Kazuki Fukui
      • Yokohama, Kanagawa, Japan, 236-0037
        • Recruiting
        • Yokohama Minami Kyosai Hospital
        • Principal Investigator:
          • Makoto Suzuki
    • Tokyo
      • Hachioji, Tokyo, Japan, 192-0918
        • Recruiting
        • Minamino Cardiovascular Hospital
        • Principal Investigator:
          • Yoshiki Hata
      • Ome, Tokyo, Japan, 198-0042
        • Recruiting
        • Ome Municipal General Hospital
        • Principal Investigator:
          • Yuichi Ono
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506
        • Recruiting
        • Yamanashi Prefectural Central Hospital
        • Contact:
          • Phone Number: 0552537111
        • Principal Investigator:
          • Ken Umetani
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-231
        • Recruiting
        • NZOZ Centrum Medyczne KERmed
        • Contact:
          • Phone Number: 48600249404
        • Principal Investigator:
          • Tomasz Lugowski
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-605
        • Recruiting
        • INTERCOR
        • Contact:
          • Phone Number: 48603127021
        • Principal Investigator:
          • Grzegorz Grzesk
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-044
        • Recruiting
        • CenterMed Lublin NZOZ
        • Contact:
          • Phone Number: 48601651647
        • Principal Investigator:
          • Grzegorz Drelich
      • Lublin, Lubelskie, Poland, 20-043
        • Not yet recruiting
        • 1 Wojskowy Szpital Kliniczny w Lublinie
        • Principal Investigator:
          • Grzegorz Sobieszek
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 01-249
        • Not yet recruiting
        • Balsam Medica
        • Principal Investigator:
          • Marcin Grabowski
    • Małopolskie
      • Krakow, Małopolskie, Poland, 30-082
        • Recruiting
        • Private Practice - Dr. Ewa Mirek Bryniarska
        • Principal Investigator:
          • Ewa Mirek-Bryniarska
      • Oświęcim, Małopolskie, Poland, 32-660
        • Recruiting
        • MEDICOME Centrum Badań Klinicznych Oświęcimskie
        • Contact:
          • Phone Number: 48505121703
        • Principal Investigator:
          • Witold Zmuda
    • Podkarpackie
      • Przemysl, Podkarpackie, Poland, 37-700
        • Recruiting
        • Wojewódzki Szpital im. Sw. Ojca Pio w Przemyslu
        • Principal Investigator:
          • Lukasz Wisniowski
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-704
        • Recruiting
        • KLIMED Marek Klimkiewicz
        • Contact:
          • Phone Number: 0048603157778
        • Principal Investigator:
          • Marzena Ewa Ginel
      • Białystok, Podlaskie, Poland, 15-540
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny w Białymstoku
        • Principal Investigator:
          • Anna Tomaszuk-Kazberuk
    • Łódzkie
      • Piotrkow Trybunalski, Łódzkie, Poland, 97-300
        • Recruiting
        • Provita Profamilia
        • Contact:
          • Phone Number: 692050663
        • Principal Investigator:
          • Ewa Kalecinska-Krystkiewicz
      • Piotrkow Trybunalski, Łódzkie, Poland, 97-300
        • Recruiting
        • IRMED Osrodek Badan Klinicznych
        • Contact:
          • Phone Number: 48447890484
        • Principal Investigator:
          • TOMASZ CIURUS
      • Łódź, Łódzkie, Poland, 90-549
        • Not yet recruiting
        • SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital Wetera -T
        • Principal Investigator:
          • Malgorzata Lelonek
      • Łódź, Łódzkie, Poland, 93-513
        • Not yet recruiting
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
        • Principal Investigator:
          • Grzegorz Piotrowski
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 De Octubre
        • Principal Investigator:
          • Juan Francisco Delgado
    • A Coruña [La Coruña]
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario
        • Contact:
          • Phone Number: 340981955740
        • Principal Investigator:
          • Jose Ramon Gonzalez-Juanatey
    • Alicante
      • Dénia, Alicante, Spain, 03700
        • Recruiting
        • Hospital de Denia Marina Salud
        • Principal Investigator:
          • ALFONSO VALLE
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Principal Investigator:
          • Juan Carlos Castillo Dominguez
      • Sevilla, Andalucía, Spain, 41014
        • Recruiting
        • Hospital Universitario Virgen de Valme
        • Principal Investigator:
          • Antonio Reyes Dominguez
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
          • Phone Number: 934978915
        • Principal Investigator:
          • Antoni Bayes Genis
    • Catalunya [Cataluña]
      • L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
          • Phone Number: 0034932607078
        • Principal Investigator:
          • Cristina Enjuanes Grau
    • Jaén
      • Ubeda, Jaén, Spain, 23400
        • Recruiting
        • Hospital San Juan de la Cruz
        • Contact:
          • Phone Number: 671560156
        • Principal Investigator:
          • Juan Luis Bonilla Palomas
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Phone Number: 34913368000
        • Principal Investigator:
          • PAU LLACER IBORRA
    • Murcia, Región De
      • El Palmar, Murcia, Murcia, Región De, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
        • Contact:
          • Phone Number: 34968369445
        • Principal Investigator:
          • Domingo Pascual Figal
    • Málaga
      • Malaga, Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Phone Number: 620441434
        • Principal Investigator:
          • Juan Jose Gomez Doblas
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
        • Contact:
          • Phone Number: 34961973520
        • Principal Investigator:
          • Julio Nunez Villota
  • Turkey
      • Afyonkarahisar, Turkey, 03200
        • Not yet recruiting
        • Afyon Kocatepe Üniversitesi Tıp Fakültesi
        • Principal Investigator:
          • Ersel Onrat
      • Ankara, Turkey, 06170
        • Not yet recruiting
        • Ankara Etlik City Hospital
        • Principal Investigator:
          • Hakan Gullu
      • Edirne, Turkey, 22030
        • Not yet recruiting
        • Trakya University
        • Principal Investigator:
          • Servet Altay
      • Kocaeli, Turkey, 41380
        • Not yet recruiting
        • Kocaeli Üniversitesi
        • Principal Investigator:
          • Tayfun Sahin
      • Mersin, Turkey, 33343
        • Not yet recruiting
        • Mersin University
        • Principal Investigator:
          • Turkay Ozcan
      • İzmir, Turkey, 35340
        • Not yet recruiting
        • Dokuz Eylul Universitesi Hastanesi
        • Principal Investigator:
          • MEHMET BIRHAN YILMAZ
    • Bursa
      • Yıldırım, Bursa, Turkey, 16310
        • Not yet recruiting
        • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
        • Principal Investigator:
          • Hasan ARI
    • Eskişehir
      • Eskisehir, Eskişehir, Turkey, 26480
        • Not yet recruiting
        • Eskisehir Osmangazi University
        • Principal Investigator:
          • Yuksel Cavusoglu
    • İzmir
      • Bornova, İzmir, Turkey, 35100
        • Not yet recruiting
        • Ege Universitesi Hastanesi
        • Principal Investigator:
          • Latife Kayikcioglu
  • United Kingdom
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • Aintree University Hospital NHS Foundation Trust
        • Contact:
          • Phone Number: 01515292708
        • Principal Investigator:
          • Prathap Kanagala
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Wythenshawe Hospital
        • Principal Investigator:
          • Chris Miller
      • Reading, United Kingdom, RG1 5AN
        • Not yet recruiting
        • Royal Berkshire Hospital
        • Principal Investigator:
          • Charlie McKenna
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
        • Recruiting
        • Wycombe General Hospital
        • Contact:
          • Phone Number: 01494425958
        • Principal Investigator:
          • Mayooran Shanmuganathan
    • Highland
      • Inverness, Highland, United Kingdom, IV2 3JH
        • Recruiting
        • Raigmore Hospital
        • Principal Investigator:
          • Stephen James Leslie
    • London, City Of
      • Harrow, London, City Of, United Kingdom, HA1 3UJ
        • Recruiting
        • Northwick Park Hospital
        • Contact:
          • Phone Number: 02088692548
        • Principal Investigator:
          • Hugh Bethell
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Recruiting
        • Glasgow Royal Infirmary
        • Contact:
          • Phone Number: 01412114833
        • Principal Investigator:
          • Mark Petrie
  • United States
    • California
      • Covina, California, United States, 91723
        • Recruiting
        • Valley Clinical Trials, Inc.
        • Principal Investigator:
          • Fahed G Bitar
        • Contact:
          • Phone Number: 626-598-4952
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials, Inc.
        • Principal Investigator:
          • Mehrdad Ariani
      • Pasadena, California, United States, 91105
        • Recruiting
        • Pasadena Clinical Research
        • Principal Investigator:
          • Fahed Bitar
      • Santa Ana, California, United States, 92704
        • Recruiting
        • Velocity Clinical Research, Coastal Heart Medical Group
        • Contact:
          • Phone Number: 714-290-5322
        • Principal Investigator:
          • Anil Shah
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Excel Medical Clinical Trials
        • Contact:
          • Phone Number: 561-756-8206
        • Principal Investigator:
          • DAVID FUNT
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • South Florida Research Solutions - North Flamingo Road
        • Contact:
          • Phone Number: 954-986-3067
        • Principal Investigator:
          • Julio Tallet
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Principal Investigator:
          • Frank W. Smart
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
          • Phone Number: 617-638-8060
        • Principal Investigator:
          • David Pimentel
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Phone Number: 313-916-6375
        • Principal Investigator:
          • David Lanfear
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center
        • Contact:
          • Phone Number: 919-843-5223
        • Principal Investigator:
          • Kirkwood F Adams
    • Texas
      • Amarillo, Texas, United States, 79109
        • Completed
        • PharmaTex Research
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • Alvin Chandra
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Health-Advanced Heart and Lung Disease
        • Contact:
          • Phone Number: 2148206856
        • Principal Investigator:
          • Cesar Yvan Guerrero-Miranda
      • Galveston, Texas, United States, 77555-0553
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
          • Phone Number: 409-772-1533
        • Principal Investigator:
          • Wissam Khalife
      • Houston, Texas, United States, 77094
        • Recruiting
        • West Houston Area Clinical Trial Consultants
        • Principal Investigator:
          • James Feldman
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Institute of Cardiology, PA
        • Contact:
          • Phone Number: 214-544-7555
        • Principal Investigator:
          • Faisal Wahid
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • University of Wisconsin Hospitals and Clinics
        • Principal Investigator:
          • Aurangzeb Baber
        • Contact:
          • Phone Number: 608-263-0080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3540378 Dose 1
Participants will receive LY3540378 subcutaneously (SC).
Drug: LY3540378
Administered SC
Experimental: LY3540378 Dose 2
Participants will receive LY3540378 SC.
Drug: LY3540378
Administered SC
Experimental: LY3540378 Dose 3
Participants will receive LY3540378 SC.
Drug: LY3540378
Administered SC
Placebo Comparator: Placebo
Participants will be given placebo SC.
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Left Atrial Reservoir Strain (LARS)
Time Frame: Baseline, Week 26
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI)
Time Frame: Baseline, Week 26
Baseline, Week 26
Change from Baseline Left Atrial End-Systolic Volume Index (LAESVI)
Time Frame: Baseline, Week 26
Baseline, Week 26
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, Week 26
eGFR calculated by creatinine and cystatin C
Baseline, Week 26
Change from Baseline in Serum Creatinine
Time Frame: Baseline, Week 26
Baseline, Week 26
Change from Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Time Frame: Baseline, Week 26
Baseline, Week 26
Change from Baseline in cystatin-C
Time Frame: Baseline, Week 26
Baseline, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Estimated)

November 27, 2024

Study Completion (Estimated)

January 8, 2025

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18473
  • J3E-MC-EZDB (Other Identifier: Eli Lilly and Company)
  • 2023-505902-40-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe