Heart Failure Clinical Trial

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity

Summary

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

View Full Description

Full Description

The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be 120 weeks and will depend on duration of study enrollment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%
Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure
Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,
Stable dose of heart failure medications within 4 weeks of screening
Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)
6MWD 100-425m
KCCQ CSS ≤80

Exclusion Criteria:

Have had a major cardiovascular event within the last 90 days of screening
Have had acute decompensated heart failure within 4 weeks of screening
Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions
Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease
HbA1c ≥9.5% or uncontrolled diabetes
History of proliferative diabetic retinopathy or diabetic maculopathy
Have a history of pancreatitis
eGFR <15 mL/min/1.73 m² or requiring dialysis at screening

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT04847557

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 135 Locations for this study

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Heart Center Research
Huntsville Alabama, 35801, United States More Info
Contact
256-519-8280
Kaushik Jain
Principal Investigator
Westside Medical Associates of Los Angeles
Beverly Hills California, 90211, United States More Info
Contact
310-289-9955
Norman Lepor
Principal Investigator
Valley Clinical Trials, Inc.
Covina California, 91723, United States More Info
Contact
626-598-4952
Fahed G Bitar
Principal Investigator
Amicis Research Center
Granada Hills California, 91344, United States More Info
Contact
818-924-4708
sunil rangappa
Principal Investigator
University of California San Diego - La Jolla
La Jolla California, 92037, United States More Info
Contact
858-246-2996
Kimberly Hong
Principal Investigator
Valley Clinical Trials, Inc.
Northridge California, 91325, United States More Info
Mehrdad Ariani
Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance California, 90502, United States More Info
Contact
310-222-1202
William J. French
Principal Investigator
South Denver Cardiology Associates, PC
Littleton Colorado, 80120, United States More Info
Grant Bailey
Principal Investigator
Cardiology Associates of Fairfield County, P.C.
Stamford Connecticut, 06905, United States More Info
Contact
203-353-1133
Thomas Nero
Principal Investigator
Excel Medical Clinical Trials
Boca Raton Florida, 33434, United States More Info
Contact
561-756-8206
Seth J. Baum
Principal Investigator
Clearwater Cardiovascular & Interventional Consultants
Clearwater Florida, 33756, United States More Info
Contact
727-451-0523
Marilyn King
Principal Investigator
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Largo Florida, 33777, United States More Info
Jay K Amin
Principal Investigator
Infinite Clinical Research
Miami Florida, 33133, United States More Info
Contact
7866313674
Jose Enrique Escalante
Principal Investigator
Ocala Cardiovascular Research
Ocala Florida, 34471, United States More Info
Contact
352-421-5316
Lan Luo
Principal Investigator
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Safety Harbor Florida, 34695, United States More Info
Contact
727-467-9393
Andrew DeWolfe
Principal Investigator
East Coast Institute for Research - St. Augustine
Saint Augustine Florida, 32086, United States More Info
Contact
904-310-1845
Ferris George
Principal Investigator
Morehouse School Of Medicine
Atlanta Georgia, 30310, United States More Info
Melvin R Echols
Principal Investigator
St. Luke's Boise Medical Center
Boise Idaho, 83712, United States More Info
Contact
2088303677
David Andrew Hinchman
Principal Investigator
Northwest Heart Clinical Research
Arlington Heights Illinois, 60005, United States More Info
Contact
847-483-0690
Steven Lupovitch
Principal Investigator
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States More Info
Alexander Adler
Principal Investigator
Cardiovascular Research of Northwest Indiana
Munster Indiana, 46321, United States More Info
Contact
219-934-4200
Ravi S. Bhagwat
Principal Investigator
Midwest Heart & Vascular Specialists
Overland Park Kansas, 66211, United States More Info
Contact
913-253-3000
Lloyd D. Stahl
Principal Investigator
Grace Research - Bossier
Bossier City Louisiana, 71111, United States More Info
Contact
3186387309
William Britton Eaves
Principal Investigator
The Heart Clinic - Hammond
Hammond Louisiana, 70403, United States More Info
Contact
985-269-7106
Ghiath Mikdadi
Principal Investigator
Grace Research - Shreveport
Shreveport Louisiana, 71105, United States More Info
Contact
318-626-5180
Anil Chhabra
Principal Investigator
Maryland Cardiovascular Specialists
Baltimore Maryland, 21229, United States More Info
Contact
443-798-2670
Jeffrey F. Cole
Principal Investigator
McLaren Bay Region
Bay City Michigan, 48708, United States More Info
Yousef Hisham Bader
Principal Investigator
St. Louis Heart and Vascular, P.C.
Saint Louis Missouri, 63136, United States More Info
Harvey Serota
Principal Investigator
Palm Research Center Tenaya
Las Vegas Nevada, 89128, United States More Info
Contact
702-826-2795
navid kazemi
Principal Investigator
Lovelace Medical Center
Albuquerque New Mexico, 87102, United States More Info
Contact
505-221-1313
Faisal Zaeem
Principal Investigator
Erie County Medical Center
Buffalo New York, 14215, United States More Info
Contact
716-898-5625
Joseph L Izzo
Principal Investigator
Rochester General Hospital
Rochester New York, 14621, United States More Info
Contact
5859229800
Elizabeth Carol Lee
Principal Investigator
Saratoga Cardiology Associates
Saratoga Springs New York, 12866, United States More Info
Contact
518-693-0186
David D. Kandath
Principal Investigator
Stony Brook University
Stony Brook New York, 11794, United States More Info
Contact
631-444-2031
Hal Skopicki
Principal Investigator
OnSite Clinical Solutions
Charlotte North Carolina, 28277, United States More Info
Contact
800-785-3150
James M Maher
Principal Investigator
Rama Research
Marion Ohio, 43302, United States More Info
Contact
740-383-7039
Bhola N Rama
Principal Investigator
Hightower Clinical Trial Services
Oklahoma City Oklahoma, 73102, United States More Info
Faisal Latif
Principal Investigator
Hillsboro Cardiology
Hillsboro Oregon, 97123, United States
Capital Area Research, LLC
Camp Hill Pennsylvania, 17011, United States More Info
Contact
717-441-1725
Venkatesh K Nadar
Principal Investigator
Doylestown Hospital
Doylestown Pennsylvania, 18901, United States More Info
Contact
267-893-6420
Renee Sangrigoli
Principal Investigator
UPMC Clinical Trials
Pittsburgh Pennsylvania, 15213, United States More Info
Contact
412-802-3131
Brittany Palmer
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Contact
843-792-5873
Sheldon Litwin
Principal Investigator
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
Rapid City South Dakota, 57701, United States More Info
Contact
605-755-4326
Alexander Schabauer
Principal Investigator
Apex Research Foundation
Jackson Tennessee, 38301, United States More Info
Contact
731-423-8200
Mohsin Alhaddad
Principal Investigator
DiscoveResearch
Beaumont Texas, 77701, United States More Info
Contact
409-813-1190
Mark Fasulo
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Alvin Chandra
Principal Investigator
North Dallas Research Associates
McKinney Texas, 75069, United States More Info
Contact
9725622345
Muhammad Akram Khan
Principal Investigator
Sherman Clinical Research
Sherman Texas, 75092, United States More Info
Contact
9037714093
Nikhil Shashikant Joshi
Principal Investigator
Northwest Houston Heart Center
Tomball Texas, 77375, United States More Info
Contact
2813514911
Ahmad Adnan Aslam
Principal Investigator
Intermountain Medical Center
Murray Utah, 84107, United States More Info
Contact
801-507-4637
Rami Alharethi
Principal Investigator
Pulse Heart Institute
Puyallup Washington, 98372, United States More Info
Contact
210-260-3434
Ahmad Slim
Principal Investigator
West Virginia University
Morgantown West Virginia, 26506, United States More Info
George Gus Sokos
Principal Investigator
DIM Clínica Privada
Ramos Mejía Buenos Aires, B1704, Argentina More Info
Contact
5401146562828
Oscar Romano Montaña
Principal Investigator
Go Centro Medico San Nicolás
San Nicolas Buenos Aires, 2900, Argentina More Info
Contact
5493415597777
Marisa Liliana Vico
Principal Investigator
Fundación Respirar
Buenos Aires Buenos Air, C1426, Argentina More Info
Contact
47815331
Maan Sarem
Principal Investigator
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire Buenos Air, C1027, Argentina More Info
Contact
541152364056
Angela Maria Romero Zarante
Principal Investigator
Mautalen Salud e Investigación
Buenos Aires Ciudad Aut, C1128, Argentina More Info
Contact
541145143400
Daniel Agustin Chirino Navarta
Principal Investigator
CIPREC
Buenos Aires Ciudad Autónoma De Buenos Aire, C1061, Argentina More Info
Contact
5491144074402
Cesar Javier Zaidman
Principal Investigator
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire, C1425, Argentina More Info
Contact
5401148019001
Sonia Angelica Sassone
Principal Investigator
Instituto de Investigaciones Clínicas Rosario - Sanatorio Delta
Rosario Santa Fe, 2000, Argentina More Info
Contact
543414473997
Jorgelina Mariana Sala
Principal Investigator
Instituto Médico Especializado (IME)
Buenos Aires , 1405, Argentina More Info
Claudio Cosman
Principal Investigator
CEMEDIC
Buenos Aires , C1407, Argentina More Info
Contact
541146356624
Claudio R. Majul
Principal Investigator
Instituto de Cardiología "Juana F. Cabral"
Corrientes , 3400, Argentina More Info
Contact
5493794788655
Julio Andres Vallejos
Principal Investigator
Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
Córdoba , X5002, Argentina More Info
Contact
5493515488775
Jorge Hector Resk
Principal Investigator
Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
Formosa , 3600, Argentina More Info
Contact
03704555398
Liza Maria Marcela Wenetz
Principal Investigator
Centro Cardiovascular Salta
Salta , 4400, Argentina More Info
Contact
543874229619
Ricardo Alfonso Leon de la Fuente
Principal Investigator
Instituto Cardiovascular San Luis
San Luis , 5700, Argentina More Info
Contact
542664440640
Juan Pablo Albisu Di Gennaro
Principal Investigator
Centro de Investigaciones Clinicas del Litoral
Santa Fe , S3000, Argentina More Info
Contact
5403424562779
Miguel Hominal
Principal Investigator
Universidade Federal de Goias
Goiania Goiás, 74605, Brazil More Info
Contact
556232698335
Aguinaldo F. Freitas
Principal Investigator
Hospital Angelina Caron
Campina Grande do Sul Paraná, 83430, Brazil More Info
Contact
554136798783
Dalton Bertolim Precoma
Principal Investigator
Centro de Pesquisa Clinica do Coracao
Aracaju Sergipe, 49055, Brazil More Info
Contact
5579999870794
FÁBIO SERRA SILVEIRA
Principal Investigator
Instituto de Pesquisa clinica de Campinas
Campinas São Paulo, 13060, Brazil More Info
Contact
1932670023
Jose Francisco Kerr Saraiva
Principal Investigator
Centro de Pesquisa Sao Lucas
Campinas São Paulo, 13060, Brazil More Info
Contact
551933438526
Aloisio Marchi Rocha
Principal Investigator
Loema Instituto de Pesquisa Clinica
Campinas São Paulo, 13092, Brazil More Info
Contact
551932353575
Maria Helena Vidotti
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
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto São Paulo, 15090, Brazil More Info
Lilia Nigro Maia
Principal Investigator
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro , 20241, Brazil More Info
Contact
552125277979
Fabio Antonio Abrantes Tuche
Principal Investigator
CEPIC - Centro Paulista de Investigação Clínica
São Paulo , 04266, Brazil More Info
Contact
551122713450
Fernando Brunori
Principal Investigator
Peking University First Hospital
Beijing Beijing, 10003, China More Info
Wenhui Ding
Principal Investigator
Beijing Friendship Hospital Affiliate of Capital University
Beijing Beijing, 10005, China More Info
Aidong Shen
Principal Investigator
Lanzhou university second hospital
Lanzhou Gansu, 73003, China More Info
Contact
8613893607559
Jing Yu
Principal Investigator
The First Affiliated Hospital of Harbin Medical University
Harbin Heilongjiang, 15000, China More Info
Lu Fu
Principal Investigator
Wuhan University Medical College - Hubei Zhongshan Hospital
Wuhan Hubei, 43000, China More Info
Contact
15307151800
Jingyi Zhang
Principal Investigator
The Third Xiangya Hospital of Central South University
Changsha Hunan, 41001, China More Info
Weihong Jiang
Principal Investigator
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou Inner Mongolia, 14010, China More Info
Contact
13634728406
Xuefeng Lin
Principal Investigator
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing Jiangsu, 21000, China More Info
Biao Xu
Principal Investigator
The Second Affiliated Hospital of Nanjing Medical University
Nanjing Jiangsu, 21001, China More Info
Contact
17768136543
Mingzhi Long
Principal Investigator
The Second Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China More Info
Contact
8613870885171
Yanqing Wu
Principal Investigator
Pingxiang People's Hospital
Pingxiang Jiangxi, 33705, China More Info
Wenjun Huang
Principal Investigator
Jilin Province People's Hospital
Changchun Jilin, 13002, China More Info
Xuelian Zhang
Principal Investigator
China-Japan Union Hospital
Changchun Jilin, 13003, China More Info
Contact
8613944111519
Ping Yang
Principal Investigator
The first affiliated hospital of dalian medical university
Dalian Shi Liaoning, 11600, China More Info
Yinong Jiang
Principal Investigator
The People's Hospital of Liaoning Province
Shenyang Liaoning, 11000, China More Info
Aijie Hou
Principal Investigator
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an Shaanxi, 71006, China More Info
Contact
862985323819
Zuyi Yuan
Principal Investigator
Jinan Central Hospital
Jinan Shandong, 25001, China More Info
GuoHai Su
Principal Investigator
Zhongshan Hospital,Fudan University
Shanghai Shanghai, 20003, China More Info
Contact
13601954136
Jingmin Zhou
Principal Investigator
Huashan Hospital Affiliated Fudan University
Shanghai Shanghai, 20004, China More Info
Contact
862152888281
Yong Li
Principal Investigator
West China Hospital of Sichuan University
Cheng Du Sichuan, 61004, China More Info
Yong He
Principal Investigator
The First Affiliated Hospital of Xinjiang Medical University
Urumchi Xinjiang, 83005, China More Info
Zhenyan Fu
Principal Investigator
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi Delhi, 11000, India More Info
Contact
09718599105
Vimal Mehta
Principal Investigator
Batra Hospital and Medical Research Centre
New Delhi Delhi, 11006, India More Info
Contact
9811150518
Upendra Kaul
Principal Investigator
CIMS Hospital - Care Institute of Medical Sciences
Ahmedabad Gujarat, 38006, India More Info
Urmil Girishbhai Shah
Principal Investigator
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai Maharashtra, 40001, India More Info
Contact
02224107006
Prafulla Gopinath Kerkar
Principal Investigator
Government Medical College And Hospital - Nagpur
Nagpur Maharashtra, 44000, India More Info
Vinod Yashwantrao Khandait
Principal Investigator
Central India Cardiology and Research Institute
Nagpur Maharashtra, 44001, India More Info
Contact
9822220936
Anil Ramesh Jawahirani
Principal Investigator
Vijan Hospital & Research Centre
Nashik Maharashtra, 42200, India More Info
Contact
919822025353
Vinod Vijan
Principal Investigator
AIG Hospitals
Hyderabad Telangana, 50003, India More Info
Narasimhan Calambur
Principal Investigator
Barzilai Medical Center
Ashkelon HaDarom, 78306, Israel More Info
Contact
972537678872
CHAIM Yosefy
Principal Investigator
Meir Medical Center
Kfar Saba HaMerkaz, 44281, Israel More Info
Contact
972-9-7472587
Abid Assali
Principal Investigator
Sheba Medical Center
Ramat Gan HaMerkaz, 52621, Israel More Info
Contact
97235302617
Michael Shechter
Principal Investigator
Kaplan Medical Center
Rehovot HaMerkaz, 76100, Israel More Info
Contact
97289440069
Sorel Goland
Principal Investigator
Rambam Health Care Campus
Haifa HaTsafon, 31096, Israel More Info
Contact
97247773476
oren caspi
Principal Investigator
Galilee Medical Center
Nahariya HaTsafon, 22100, Israel More Info
Contact
972507887577
Shaul Atar
Principal Investigator
Sourasky Medical Center
Tel Aviv Tell Abīb, 64239, Israel More Info
Contact
97236972557
Ben Sadeh
Principal Investigator
Shaare Zedek Medical Center
Jerusalem Yerushalayim, 90131, Israel More Info
Contact
972265376768
Tal Hasin
Principal Investigator
Hadassah Medical Center
Jerusalem Yerushalayim, 91120, Israel More Info
Contact
97226776564
Israel Gotsman
Principal Investigator
CIMAB SA de CV
Torreón Coahuila, 27000, Mexico More Info
Contact
8717130315
Alberto Esteban Bazzoni Ruiz
Principal Investigator
Virgen Cardiovascular Research SC
Guadalajara Jalisco, 44670, Mexico More Info
Luis Ramon Virgen Carrillo
Principal Investigator
Cardiolink Clin Trials
Monterrey Nuevo León, 64060, Mexico More Info
Contact
8140401554
Elías García
Principal Investigator
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes , 20230, Mexico More Info
Contact
4499171770
Edmundo Alfredo Bayram Llamas
Principal Investigator
Hospital Cardiologica Aguescalientes
Aguascalientes , 20230, Mexico More Info
Contact
524499154000
Guillermo Antonio Llamas Esperon
Principal Investigator
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro , 76000, Mexico More Info
Marco Antonio Alcocer Gamba
Principal Investigator
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Bayamon , 00956, Puerto Rico More Info
Hector L Banchs
Principal Investigator
Research and Cardiovascular Corp.
Ponce , 00717, Puerto Rico More Info
Contact
7872908585
Jose B. Vazquez-Tanus
Principal Investigator
Ivanovo Regional Healthcare Institution Cardiology Dispensary
Ivanovo Ivanovskay, 15301, Russian Federation More Info
Contact
7961246339
Elena Shutemova
Principal Investigator
Russian Cardiology Research and Production Complex
Moscow Moskva, 12155, Russian Federation More Info
Contact
+79104137499
Marat Ezhov
Principal Investigator
Russian Medical Academy of Postgraduate Education
Moscow Moskva, 25128, Russian Federation More Info
Contact
88001009602
Maria Klepikova
Principal Investigator
Ryazan Regional Clinical Cardiological Dispensary
Ryazan Ryazanskaya Oblast', 39002, Russian Federation More Info
Contact
74912768406
Sergey Yakushin
Principal Investigator
Astarta Clinic
Saint-Petersburg Sankt-Peterburg, 19922, Russian Federation More Info
Contact
78123372303
Dmitriy Vladimirovich Kositsyn
Principal Investigator
Izhevsk City Clinical Hospital Number 9
Izhevsk Udmurtskaya Respublika, 42606, Russian Federation More Info
Contact
79124656758
ANDREI EZHOV
Principal Investigator
National Taiwan University Hospital
Taipei City Taipei, 10022, Taiwan More Info
Contact
886972651070
Tzung-Dau Wang
Principal Investigator
Mackay Memorial Hospital-Hsinchu
Hsinchu , 300, Taiwan More Info
Ming-En Liu
Principal Investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan More Info
Contact
88673121101
Tsung-Hsien Lin
Principal Investigator
Chung Shan Medical University Hospital
Taichung , 402, Taiwan More Info
Kwo-Chang Ueng
Principal Investigator
Taipei Veterans General Hospital
Taipei R. O. C. , 112, Taiwan More Info
Contact
886228712121
Chern-En Chiang
Principal Investigator
Taipei Medical University Hospital
Taipei , 110, Taiwan More Info
Contact
88622737218
Chun-Yao Huang
Principal Investigator
Chang Gung Medical Foundation-Linkou Branch
Taoyuan , 333, Taiwan More Info
I-Chang Hsieh
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT04847557

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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