A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
- Conditions
- Heart FailureHeart Failure With Preserved Ejection Fraction
- Interventions
- Drug: Placebo
- Registration Number
- NCT05592275
- Lead Sponsor
- Eli Lilly and Company
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 335
-
Experienced an index event, defined as a recent hospitalization for HF requiring ≥1 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥1 bolus doses of intravenous diuretics.
-
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 600 pg/mL [atrial fibrillation or atrial flutter] OR BNP (>100 [sinus rhythm] or 200 pg/mL [atrial fibrillation or atrial flutter]) at screening.
-
eGFR of >20 mL/min/1.73 m² at V1 (screening; determined by local laboratory), derived from serum creatinine values, age, and sex based on the CKD-EPI equation.
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 V2. (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 a chronic pulmonary/lung disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
- Uncorrected thyroid disease.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will be given placebo SC. LY3540378 Dose 1 LY3540378 Participants will receive LY3540378 subcutaneously (SC). LY3540378 Dose 2 LY3540378 Participants will receive LY3540378 SC. LY3540378 Dose 3 LY3540378 Participants will receive LY3540378 SC.
- Primary Outcome Measures
Name Time Method Change from Baseline in Left Atrial Reservoir Strain (LARS) Baseline, Week 26
- Secondary Outcome Measures
Name Time Method Change from Baseline in cystatin-C Baseline, Week 26 Change from Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Baseline, Week 26 Change from Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI) Baseline, Week 26 Change from Baseline Left Atrial End-Systolic Volume Index (LAESVI) Baseline, Week 26 Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) Baseline, Week 26 eGFR calculated by creatinine and cystatin C
Change from Baseline in Serum Creatinine Baseline, Week 26
Trial Locations
- Locations (136)
Pima Heart
🇺🇸Tucson, Arizona, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Pasadena Clinical Research
🇺🇸Pasadena, California, United States
Mayo Clinic in Rochester, Minnesota
🇺🇸Rochester, Minnesota, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
PharmaTex Research
🇺🇸Amarillo, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
Velocity Clinical Research, Coastal Heart Medical Group
🇺🇸Santa Ana, California, United States
Infinite Clinical Research
🇺🇸Miami, Florida, United States
South Florida Research Solutions - North Flamingo Road
🇺🇸Pembroke Pines, Florida, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Baylor Scott & White Health-Advanced Heart and Lung Disease
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
West Houston Area Clinical Trial Consultants
🇺🇸Houston, Texas, United States
Texas Institute of Cardiology, PA
🇺🇸McKinney, Texas, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate
🇦🇷Zárate, Buenos Aires, Argentina
Centro de Investigaciones Clinicas del Litoral
🇦🇷Santa Fe, Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
🇦🇷Santa Fe, Argentina
Investigaciones Medicas Imoba Srl
🇦🇷Balvanera, Ciudad Autónoma De Buenos Aires, Argentina
Sanatorio Anchorena Recoleta
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
Hospital Provincial del Centenario
🇦🇷Rosario, Santa Fe, Argentina
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Sanatorio San Martin
🇦🇷Venado Tuerto, Santa Fe, Argentina
Centro de Pesquisa Silvestre Santé
🇧🇷Rio Branco, Acre, Brazil
Investigaciones Clínicas Tucumán
🇦🇷San Miguel de Tucuman, Tucumán, Argentina
CEMEDIC
🇦🇷Buenos Aires, Argentina
Fundación Respirar
🇦🇷Buenos Aires, Argentina
Universidade Federal de Goias
🇧🇷Goiania, Goiás, Brazil
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
🇧🇷Curitiba, Paraná, Brazil
Centro de Pesquisa Clinica do Coracao
🇧🇷Acaraju, Sergipe, Brazil
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
Instituto de Pesquisa clinica de Campinas
🇧🇷Campinas, São Paulo, Brazil
Instituto Do Coracao De Marilia
🇧🇷Marilia, São Paulo, Brazil
CAPED Centro Avancado Pesquisa e Diagnostica
🇧🇷Ribeirao Preto, São Paulo, Brazil
Pesquisare Saude
🇧🇷Santo André, São Paulo, Brazil
Hospital Santa Paula
🇧🇷Sao Paulo, São Paulo, Brazil
Incor - Instituto do Coracao
🇧🇷Sao Paulo, São Paulo, Brazil
Instituto de Molestias Cardiovasculares de Tatui
🇧🇷Tatui, São Paulo, Brazil
Integral Pesquisa e Ensino
🇧🇷Votuporanga, São Paulo, Brazil
Hospital São Lucas de Copacabana
🇧🇷Rio de Janeiro, Brazil
Instituto D'Or Pesquisa e Ensino
🇧🇷Rio de Janeiro, Brazil
SMH Cardiology Clinical Trials
🇨🇦Surrey, British Columbia, Canada
Private Practice - Dr. Saul Vizel
🇨🇦Cambridge, Ontario, Canada
PACE Cardiology
🇨🇦Newmarket, Ontario, Canada
North York Diagnostic and Cardiac Centre
🇨🇦North York, Ontario, Canada
Oakville Trafalgar Memorial Hospital
🇨🇦Oakville, Ontario, Canada
Heart Health Institute - Scarborough Office
🇨🇦Scarborough, Ontario, Canada
Medicus MFC Research Clinic
🇨🇦Toronto, Ontario, Canada
CPS Research
🇨🇦Waterloo, Ontario, Canada
Centre Hospitalier Universite de Sherbrooke - Hôtel-Dieu Hospital
🇨🇦Sherbrooke, Quebec, Canada
Fakultní nemocnice Brno Bohunice
🇨🇿Brno, Brno-město, Czechia
Fakultni Nemocnice u sv. Anny v Brne
🇨🇿Brno, Jihomoravský Kraj, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Medifarma 98 Kft
🇭🇺Nyiregyhaza, Nyíregyháza, Hungary
Kistarcsai Flor Ferenc Korhaz
🇭🇺Kistarcsa, Pest, Hungary
Belvárosi Egészségház
🇭🇺Zalaegerszeg, Zala, Hungary
Dél-Pesti Centrumkórház
🇭🇺Budapest, Hungary
Semmelweis University
🇭🇺Budapest, Hungary
Yitzhak Shamir Medical Center
🇮🇱Zerifin, HaMerkaz, Israel
Rambam Health Care Campus
🇮🇱Haifa, HaTsafon, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Kasugai Municipal Hospital
🇯🇵Kasugai, Aichi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
🇯🇵Nagoya, Aichi, Japan
Saiseikai Futsukaichi Hospital
🇯🇵Chikushino, Fukuoka, Japan
Nakamura Cardiovascular Clinic
🇯🇵Itoshima, Fukuoka, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
National Hospital Organization Takasaki General Medical Centar
🇯🇵Takasaki, Gunma, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Yokohama Minami Kyosai Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Yokohama, Kanagawa, Japan
Minamino Cardiovascular Hospital
🇯🇵Hachioji, Tokyo, Japan
Ome Medical Center
🇯🇵Ome, Tokyo, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Kofu, Yamanashi, Japan
Harasanshin Hospital
🇯🇵Fukuoka, Japan
Rakuwakai Otowa Hospital
🇯🇵Kyoto, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama, Japan
Sakurabashi Watanabe Advanced Healthcare Hospital
🇯🇵Osaka, Japan
Yodogawa Christian Hospital
🇯🇵Osaka, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
🇯🇵Osaka, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama, Japan
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Hospital de Denia Marina Salud
🇪🇸Dénia, Alicante, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Andalucía, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Andalucía, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona [Barcelona], Spain
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital San Juan de la Cruz
🇪🇸Ubeda, Jaén, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Madrid, Comunidad De, Spain
INTERCOR
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
CenterMed Lublin NZOZ
🇵🇱Lublin, Lubelskie, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
🇵🇱Białystok, Podlaskie, Poland
1 Wojskowy Szpital Kliniczny w Lublinie
🇵🇱Lublin, Lubelskie, Poland
Balsam Medica
🇵🇱Warsaw, Mazowieckie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
🇵🇱Przemysl, Podkarpackie, Poland
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital Wetera -T
🇵🇱Łódź, Łódzkie, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
🇵🇱Łódź, Łódzkie, Poland
CHUS - Hospital Clinico Universitario
🇪🇸Santiago de Compostela, A Coruña [La Coruña], Spain
Private Practice - Dr. Ewa Mirek Bryniarska
🇵🇱Krakow, Małopolskie, Poland
MEDICOME Centrum Badań Klinicznych Oświęcimskie
🇵🇱Oświęcim, Małopolskie, Poland
KLIMED Marek Klimkiewicz
🇵🇱Białystok, Podlaskie, Poland
IRMED Osrodek Badan Klinicznych
🇵🇱Piotrkow Trybunalski, Łódzkie, Poland
Provita Profamilia
🇵🇱Piotrków Trybunalski, Łódzkie, Poland
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Murcia, Región De, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Málaga, Spain
Hospital Clinico de Valencia
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
🇹🇷Yıldırım, Bursa, Turkey
Eskisehir Osmangazi University
🇹🇷Eskisehir, Eskişehir, Turkey
Ege Universitesi Hastanesi
🇹🇷Bornova, İzmir, Turkey
Kocaeli Üniversitesi
🇹🇷Izmit, Kocaeli, Turkey
Afyon Kocatepe Üniversitesi Tıp Fakültesi
🇹🇷Afyonkarahisar, Turkey
Ankara Etlik City Hospital
🇹🇷Ankara, Turkey
Trakya University Medical Faculty Hospital
🇹🇷Edirne, Turkey
T.C. Sağlık Bakanlığı İzmir Tepecik Eğitim ve Araştırma Hast
🇹🇷Izmir, Turkey
Dokuz Eylul Universitesi Hastanesi
🇹🇷Izmir, Turkey
Mersin University
🇹🇷Mersin, Turkey
Wycombe General Hospital
🇬🇧High Wycombe, Buckinghamshire, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Highland, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, London, City Of, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
West Middlesex University Hospital
🇬🇧Isleworth, United Kingdom
Aintree University Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom