Studie med Omecamtiv Mecarbil (CK-1827452) for å behandle kronisk hjertesvikt med sterkt redusert ejeksjonsfraksjon (COMET-HF)
7. oktober 2026 oppdatert av: Cytokinetics
En multisenter, dobbeltblind, randomisert, placebokontrollert studie for å vurdere effektiviteten og sikkerheten til Omecamtiv Mecarbil hos pasienter med symptomatisk hjertesvikt med alvorlig redusert ejeksjonsfraksjon (COMET-HF)
The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF).
Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed.
Estimated duration of participation: Up to 3 years.
Studietype
Intervensjonell
Registrering (Antatt)
1800
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Cytokinetics MD
- Telefonnummer: (650) 624-2929
- E-post: medicalaffairs@cytokinetics.com
Studiesteder
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Alberta
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Edmonton, Alberta, Canada, T6G2B7
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- Mazankowski Alberta Heart Institute / University of Alberta Hospital
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British Columbia
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Kelowna, British Columbia, Canada, V1Y1T2
- Rekruttering
- Kelowna General Hospital
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Surrey, British Columbia, Canada, V3V0C6
- Rekruttering
- SMH - Cardiology Clinical Trials Inc.
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Vancouver, British Columbia, Canada, V6Z1Y6
- Rekruttering
- St. Paul's Hospital
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Victoria, British Columbia, Canada, V8R1B2
- Rekruttering
- Victoria Heart Institute Foundation
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Manitoba
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Winnipeg, Manitoba, Canada, R2H2A6
- Rekruttering
- St. Boniface Hospital
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Rekruttering
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A5A5
- Rekruttering
- London Health Sciences Centre
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Oakville, Ontario, Canada, L6M0L8
- Rekruttering
- Oakville Trafalgar Memorial Hospital - Halton Healthcare
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Toronto, Ontario, Canada, M4N1J7
- Rekruttering
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5B1W8
- Rekruttering
- St. Michael's Hospital
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Toronto, Ontario, Canada, M5G2C4
- Rekruttering
- UHN-Toronto General Hospital
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Quebec
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Montreal, Quebec, Canada, H1T1C8
- Rekruttering
- Montreal Heart Institute
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Sherbrooke, Quebec, Canada, J1L0H8
- Tilbaketrukket
- Diex Recherche Sherbrooke
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Terrebonne, Quebec, Canada, J6V 2H2
- Rekruttering
- CISSSL - Hopital Pierre-Le Gardeur
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Alabama
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Alexander City, Alabama, Forente stater, 35010
- Rekruttering
- Advanced Cardiovascular, LLC
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Birmingham, Alabama, Forente stater, 35233
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- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Forente stater, 85741
- Tilbaketrukket
- Pima Heart and Vascular Clinical Research
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California
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Beverly Hills, California, Forente stater, 90211
- Rekruttering
- National Heart Institute
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La Jolla, California, Forente stater, 92037
- Rekruttering
- UC San Diego Health - Sulpizio Cardiovascular Center
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Loma Linda, California, Forente stater, 92350
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- Nutrition Research Center (SPH)
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Los Angeles, California, Forente stater, 90033
- Rekruttering
- Keck Medical Center of USC (outpatient clinic)
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Los Angeles, California, Forente stater, 90095
- Rekruttering
- UCLA Medical Center Cardiovascular Clinic
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Orange, California, Forente stater, 92868
- Rekruttering
- University of California, Irvine Medical Center
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Sacramento, California, Forente stater, 95817
- Rekruttering
- UC Davis Health
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Sacramento, California, Forente stater, 95816
- Rekruttering
- Sutter Institute for Medical Research (SIMR)
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San Diego, California, Forente stater, 92123
- Rekruttering
- San Diego Cardiac Center
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San Francisco, California, Forente stater, 94109
- Rekruttering
- California Pacific Medical Center Van Ness Campus
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Santa Clara, California, Forente stater, 95051
- Rekruttering
- Kaiser Permanente Santa Clara
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Stanford, California, Forente stater, 94303
- Rekruttering
- Stanford University Hospital / Stanford Health Care
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Torrance, California, Forente stater, 90502
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- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
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- Rocky Mountain Regional VA Medical Center
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Connecticut
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Bridgeport, Connecticut, Forente stater, 06606
- Rekruttering
- Cardiology Associates of Fairfield County, P.C
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Hartford, Connecticut, Forente stater, 06102
- Rekruttering
- Hartford Hospital
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New Haven, Connecticut, Forente stater, 06519
- Rekruttering
- Yale New Haven Health Heart & Vascular Center Outpatient Services
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Florida
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Clearwater, Florida, Forente stater, 33756
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- CHF Heart Clinical (Subject Visits & IP Shipments)
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Fort Lauderdale, Florida, Forente stater, 33308
- Rekruttering
- Holy Cross Medical Group - Cardiology Associates
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Hollywood, Florida, Forente stater, 33351
- Rekruttering
- South Florida Research Solutions, LLC
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Jacksonville, Florida, Forente stater, 32209
- Rekruttering
- UF Health Jacksonville
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Miami Beach, Florida, Forente stater, 33140
- Rekruttering
- Broward Research Center
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Ocala, Florida, Forente stater, 34471
- Rekruttering
- Ocala Cardiovascular Research
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Orlando, Florida, Forente stater, 32803
- Rekruttering
- AdventHealth
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Tampa, Florida, Forente stater, 33606
- Rekruttering
- USF Health South Tampa Center for Advanced Healthcare
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Georgia
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Atlanta, Georgia, Forente stater, 30303
- Rekruttering
- Grady Health System
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Atlanta, Georgia, Forente stater, 30322
- Rekruttering
- Emory Clinic
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Atlanta, Georgia, Forente stater, 30309
- Rekruttering
- Piedmont Atlanta Hospital
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Fayetteville, Georgia, Forente stater, 30214
- Rekruttering
- Piedmont Fayette Hospital
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Hawaii
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Honolulu, Hawaii, Forente stater, 96813
- Rekruttering
- The Queen's Medical Center - Punchbowl
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Illinois
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Naperville, Illinois, Forente stater, 60540
- Rekruttering
- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, Forente stater, 46321
- Rekruttering
- Cardiovascular Research of Northwest Indiana, LLC.
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Newburgh, Indiana, Forente stater, 47630
- Rekruttering
- Deaconess Heart Group
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Richmond, Indiana, Forente stater, 47374
- Rekruttering
- Reid Physician Associates
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- Rekruttering
- The University of Kansas Medical Center
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Overland Park, Kansas, Forente stater, 66211
- Rekruttering
- AHMG Cardiology and Surgery
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Rekruttering
- University Medical Center New Orleans
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Maine
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Bangor, Maine, Forente stater, 04401
- Rekruttering
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Rekruttering
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02111
- Rekruttering
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Rekruttering
- Henry Ford Hospital
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Missouri
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Independence, Missouri, Forente stater, 64057
- Tilbaketrukket
- Midwest Heart and Vascular Specialists, LLC
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Kansas City, Missouri, Forente stater, 64111
- Rekruttering
- Saint Luke's Hospital of Kansas City
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St Louis, Missouri, Forente stater, 63110
- Rekruttering
- Washington University Center for Advanced Medicine
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St Louis, Missouri, Forente stater, 63136
- Tilbaketrukket
- St. Louis Heart and Vascular
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Nebraska
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Omaha, Nebraska, Forente stater, 68198
- Rekruttering
- University of Nebraska Medical Center
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New Jersey
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Bridgewater, New Jersey, Forente stater, 08807
- Rekruttering
- Advanced Heart Care, LLC
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Eatontown, New Jersey, Forente stater, 07724
- Rekruttering
- Monmouth Cardiology Associates, LLC
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New York
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Albany, New York, Forente stater, 12205
- Rekruttering
- Capital Cardiology Associates
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Manhasset, New York, Forente stater, 11030
- Rekruttering
- Northwell Health North Shore University Hospital
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New York, New York, Forente stater, 10029
- Rekruttering
- Mount Sinai Hospital
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New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University Medical Center / New York - Presbyterian
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The Bronx, New York, Forente stater, 10467
- Rekruttering
- Montefiore Medical Center (Moses Campus)
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North Carolina
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Cary, North Carolina, Forente stater, 27518
- Rekruttering
- WakeMed Heart & Vascular - Cary Cardiology
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Chapel Hill, North Carolina, Forente stater, 27599-7064
- Rekruttering
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill
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Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Duke University Hospital
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Greensboro, North Carolina, Forente stater, 27401
- Rekruttering
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
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Winston-Salem, North Carolina, Forente stater, 27157
- Rekruttering
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Rekruttering
- The Lindner Research Center at the Christ Hospital
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Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic
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Marion, Ohio, Forente stater, 43302
- Tilbaketrukket
- K&R Research LLC
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Sandusky, Ohio, Forente stater, 44870
- Tilbaketrukket
- University of Hospitals North Ohio Heart
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74127
- Rekruttering
- Oklahoma State University Center for Health Sciences
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health and Science University
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Pennsylvania
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Camp Hill, Pennsylvania, Forente stater, 17011
- Rekruttering
- Capital Area Research, LLC
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Hershey, Pennsylvania, Forente stater, 17033
- Rekruttering
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Rekruttering
- Medical University of South Carolina - Gazes Research Institute
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Rekruttering
- Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
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Tennessee
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Germantown, Tennessee, Forente stater, 38138
- Rekruttering
- Stern Cardiovascular Foundation, Inc.
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Knoxville, Tennessee, Forente stater, 37934
- Rekruttering
- Tennova Healthcare-Turkey Creek Medical Center
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Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
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Tullahoma, Tennessee, Forente stater, 37388
- Rekruttering
- Tennessee Center for Clinical Trials
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Texas
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Dallas, Texas, Forente stater, 75246
- Rekruttering
- Baylor University Medical Center
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Dallas, Texas, Forente stater, 75390
- Rekruttering
- The University of Texas Southwestern Medical Center
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El Paso, Texas, Forente stater, 79902
- Tilbaketrukket
- Medresearch Inc
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Galveston, Texas, Forente stater, 77555
- Rekruttering
- University of Texas Medical Branch - UTMB
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Houston, Texas, Forente stater, 77030
- Rekruttering
- CHI St. Luke's Health Baylor College of Medicine Medical Center
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Plano, Texas, Forente stater, 75093
- Rekruttering
- Baylor Scott & White Medical Center- The Hearth Hospital
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Utah
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Murray, Utah, Forente stater, 84107
- Rekruttering
- Intermountain Medical Center
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Salt Lake City, Utah, Forente stater, 84132
- Rekruttering
- University of Utah Health
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Virginia
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Norfolk, Virginia, Forente stater, 23507
- Tilbaketrukket
- Sentara Norfolk General Hospital
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Washington
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Spokane, Washington, Forente stater, 99204
- Rekruttering
- Providence Advanced Heart Disease and Transplant
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Medical College of Wisconsin / Froedtert Hospital
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrike, 31059
- Rekruttering
- Centre Hospitalier Universitaire de Toulouse
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Hauts-de-France
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Valenciennes, Hauts-de-France, Frankrike, 59300
- Rekruttering
- Polyclinique Vauban
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35033
- Rekruttering
- CHU de Rennes - Hôpital Pontchaillou
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Isère
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La Tronche, Isère, Frankrike, 38700
- Rekruttering
- Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
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Occitanie
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Montpellier, Occitanie, Frankrike, 34295
- Rekruttering
- CHU de Montpellier- Hôpital Arnaud de Villeneuve
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Frankrike, 44277
- Rekruttering
- L'Hôpital Privé Du Confluent
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Rhône
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Bron, Rhône, Frankrike, 69677
- Rekruttering
- Hospices Civils de Lyon - Hôpital Louis Pradel
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Var
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Toulon, Var, Frankrike, 83100
- Rekruttering
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)
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Île-de-France Region
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Paris, Île-de-France Region, Frankrike, 75010
- Rekruttering
- Hôpital Lariboisière - APHP
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Paris, Île-de-France Region, Frankrike, 75015
- Rekruttering
- Hôpital Européen Georges Pompidou
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Paris, Île-de-France Region, Frankrike, 75018
- Rekruttering
- APHP - Hôpital Bichât
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Attica
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Athens, Attica, Hellas, 11527
- Rekruttering
- General Hospital of Athens ''G. Gennimatas''
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Athens, Attica, Hellas, 11527
- Rekruttering
- General Hospital of Athens ''Hippokratio''
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Athens, Attica, Hellas, 14233
- Rekruttering
- General Hospital of Nea Ionia ''Konstantopouleio-Patision''
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Chaïdári, Attica, Hellas, 12462
- Rekruttering
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H
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Voula, Attica, Hellas, 16673
- Rekruttering
- General Hospital ''Asklepieio Voulas''
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Euboea
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Chalcis, Euboea, Hellas, 34100
- Rekruttering
- General Hospital of Chalkida
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Evros
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Alexandroupoli, Evros, Hellas, 68100
- Rekruttering
- University General Hospital of Alexandroupolis
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Larissa
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Larissa, Larissa, Hellas, 41110
- Rekruttering
- University General Hospital of Larissa
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Thessaloniki
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Efkarpia, Thessaloniki, Hellas, 56403
- Rekruttering
- Papageorgiou General Hospital of Thessaloniki
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Thessaloniki, Thessaloniki, Hellas, 54636
- Rekruttering
- AHEPA University General Hospital of Thessaloniki
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Cona, Italia, 44124
- Rekruttering
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
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Roma, Italia, 00163
- Rekruttering
- IRCCS San Raffaele
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BS
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Brescia, BS, Italia, 25123
- Rekruttering
- ASST Spedali Civili di Brescia
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Emilia-Romagna
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Rimini, Emilia-Romagna, Italia, 47923
- Rekruttering
- Ospedale Infermi
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Lombardy
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Arzignano, Lombardy, Italia, 36071
- Rekruttering
- Ospedale di Arzignano
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Bergamo, Lombardy, Italia, 24127
- Rekruttering
- ASST Papa Giovanni XXIII
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Milan, Lombardy, Italia, 20138
- Rekruttering
- Centro Cardiologico Monzino
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Sesto San Giovanni, Lombardy, Italia, 20099
- Rekruttering
- IRCCS Multimedica
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MI
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Milan, MI, Italia, 20132
- Rekruttering
- IRCCS Ospedale San Raffaele
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Province of Perugia
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Perugia, Province of Perugia, Italia, 06129
- Rekruttering
- A.O. Perugia - Ospedale S.Maria della Misericordia
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-
-
-
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Haikou, Kina, 570311
- Rekruttering
- Hainan General Hospital
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Hengyang, Kina, 421001
- Rekruttering
- The First Affiliated Hospital of University of South China
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100032
- Rekruttering
- Peking University Third Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400014
- Rekruttering
- Chongqing Emergency Medical Center
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Gansu
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Lanzhou, Gansu, Kina, 730030
- Rekruttering
- Lanzhou University Second
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Guangdong
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Guangzhou, Guangdong, Kina, 511400
- Rekruttering
- The Affiliated Panyu Central Hospital of Guangzhou Medical University
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Shenzhen, Guangdong, Kina, 518053
- Rekruttering
- The University of Hong Kong-Shenzhen Hospital
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Guangxi
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Nanning, Guangxi, Kina, 530020
- Rekruttering
- The First Affiliated Hospital of Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150001
- Rekruttering
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Luoyang, Henan, Kina, 471031
- Rekruttering
- The First Affiliated Hospital of Henan University of science and Technology
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Hunan
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Changsha, Hunan, Kina, 410011
- Rekruttering
- People's Hospital of Hunan Province
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Inner Mongolia
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Chifeng, Inner Mongolia, Kina, 024005
- Rekruttering
- Affiliated Hospital of Chifeng University
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Jiangsu
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Xuzhou, Jiangsu, Kina, 221002
- Rekruttering
- The Affiliated Hospital of Xuzhou Medical University
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Yangzhou, Jiangsu, Kina, 225001
- Rekruttering
- Northern Jiangsu People's Hospital
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Jilin
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Changchun, Jilin, Kina, 130033
- Rekruttering
- China-Japan Union Hospital of Jilin University
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Shandong
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Heze, Shandong, Kina, 274002
- Rekruttering
- Heze Municipal Hospital
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Jining, Shandong, Kina, 272029
- Rekruttering
- Affiliated Hospital of Jining Medical University
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Shanxi
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Taiyuan, Shanxi, Kina, 030024
- Rekruttering
- Shanxi Cardiovascular Hospital
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Yuncheng, Shanxi, Kina, 44000
- Rekruttering
- Yuncheng Central Hospital
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Taizhou
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Linhai, Taizhou, Kina, 317000
- Rekruttering
- Zhejiang Province Taizhou Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300457
- Rekruttering
- Teda International Cardiovascular Hospital
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Tianjin, Tianjin Municipality, Kina, 300020
- Rekruttering
- Tianjin Medical University General Hospital
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-
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Bialystok, Polen, 15276
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Krakow, Polen, 31202
- Rekruttering
- Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
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Lodz, Polen, 90549
- Rekruttering
- SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
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Lodz, Polen, 92213
- Rekruttering
- SPZOZ Centralny Szpital Kliniczny UM w Lodzi
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Miechów, Polen, 32200
- Rekruttering
- Szpital Sw. Anny w Miechowie
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Opole, Polen, 45401
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznan, Polen, 61848
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Ruda Śląska, Polen, 41710
- Rekruttering
- Poradnia AKA-MED Centrum Sp. z o.o.
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Torun, Polen, 87100
- Rekruttering
- Wojewodzki Szpital Zespolony im. L. Rydygiera
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Świdnik, Polen, 21040
- Rekruttering
- Tomasz Blicharski Lubelskie Centrum Diagnostyczne
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 01249
- Rekruttering
- Balsammedica Sp. z o.o.
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Warsaw, Masovian Voivodeship, Polen, 02-097
- Rekruttering
- Centralny Szpital Kliniczny UCK WUM
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-
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A Coruña
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A Coruña, A Coruña, Spania, 15006
- Rekruttering
- Hospital Universitario A Coruña
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Santiago de Compostela, A Coruña, Spania, 15706
- Rekruttering
- Hospital Clinico Universitario de Santiago
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Barcelona
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Barcelona, Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron
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Barcelona, Barcelona, Spania, 08025
- Rekruttering
- Hospital de la Santa Creu i Sant Pau
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L'Hospitalet de Llobregat, Barcelona, Spania, 08907
- Rekruttering
- Hospital Universitari de Bellvitge
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Jaen
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Úbeda, Jaen, Spania, 23400
- Rekruttering
- Hospital San Juan de la Cruz
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Lugo
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Lugo, Lugo, Spania, 27003
- Rekruttering
- Hospital Universitario Lucus Augusti
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Madrid
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Madrid, Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Spania, 28046
- Rekruttering
- Hospital Universitario La Paz
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Majadahonda, Madrid, Spania, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro
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Murcia
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El Palmar, Murcia, Spania, 30120
- Rekruttering
- Hospital Universitario Virgen de La Arrixaca
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Pontevedra
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Vigo, Pontevedra, Spania, 36312
- Rekruttering
- CHUVI - H.U. Alvaro Cunqueiro
-
-
Salamanca
-
Salamanca, Salamanca, Spania, 37007
- Rekruttering
- Hospital Universitario de Salamanca
-
-
Sevilla
-
Seville, Sevilla, Spania, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocío
-
-
Tarragona
-
Tarragona, Tarragona, Spania, 43005
- Rekruttering
- Hospital Universitari Joan XXIII de Tarragona
-
-
Valencia
-
Valencia, Valencia, Spania, 46010
- Rekruttering
- Hospital Clínico Universitario de Valencia
-
Valencia, Valencia, Spania, 46026
- Rekruttering
- Hospital Universitari i Politecnic La Fe de Valencia
-
-
-
-
-
Basingstoke, Storbritannia, RG249NA
- Rekruttering
- Basingstoke and North Hampshire Hospital
-
Cottingham, Storbritannia, HU165JQ
- Rekruttering
- Castle Hill Hospital
-
Dudley, Storbritannia, DY12HQ
- Rekruttering
- Russells Hall Hospital
-
Dundonald, Storbritannia, BT161RH
- Rekruttering
- Ulster Hospital
-
Glasgow, Storbritannia, G40SF
- Rekruttering
- Glasgow Royal Infirmary
-
Swindon, Storbritannia, SN36BB
- Rekruttering
- Great Western Hospitals
-
-
Greater London
-
Harefield, Greater London, Storbritannia, UB96JH
- Rekruttering
- Harefield Hospital
-
-
Hampshire
-
Southampton, Hampshire, Storbritannia, SO166YD
- Rekruttering
- Southampton General Hospital
-
-
Scotland
-
Glasgow, Scotland, Storbritannia, G514TF
- Rekruttering
- Queen Elizabeth University Hospital
-
-
-
-
Baden-Wurttemberg
-
Heidelberg, Baden-Wurttemberg, Tyskland, 69120
- Rekruttering
- Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
-
-
Bavaria
-
München, Bavaria, Tyskland, 81377
- Rekruttering
- LMU Klinikum - Medizinische Klinik und Poliklinik I
-
Würzburg, Bavaria, Tyskland, 97078
- Rekruttering
- Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz
-
-
Free and Hanseatic City of Hamburg
-
Hamburg, Free and Hanseatic City of Hamburg, Tyskland, 20246
- Rekruttering
- UKE, Klinik für Kardiologie
-
Hamburg, Free and Hanseatic City of Hamburg, Tyskland, 20246
- Rekruttering
- UKE, Klinik fur Kardiologie
-
-
Germany
-
Erfurt, Germany, Tyskland, 99089
- Rekruttering
- Helios Klinikum Erfurt GmbH
-
Jena, Germany, Tyskland, 07747
- Rekruttering
- Universitaetsklinikum Jena
-
Mainz, Germany, Tyskland, 55131
- Rekruttering
- Marienhaus Klinikum Mainz GmbH
-
-
Hesse
-
Bad Nauheim, Hesse, Tyskland, 61231
- Rekruttering
- Kerckhoff-Klinik GmbH
-
Frankfurt am Main, Hesse, Tyskland, 60590
- Rekruttering
- Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
-
Langen, Hesse, Tyskland, 63225
- Rekruttering
- Asklepios Klinik Langen-Seligenstadt GmbH
-
-
Lower Saxony
-
Göttingen, Lower Saxony, Tyskland, 37075
- Rekruttering
- Universitaetsmedizin Goettingen
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Tyskland, 53127
- Rekruttering
- Universitätsklinikum Bonn
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66424
- Rekruttering
- Uniklinikum Saarland
-
-
Saxony
-
Markkleeberg, Saxony, Tyskland, 04416
- Rekruttering
- Dr. med. Jens Taggeselle
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Adult patients who meet all the following criteria at screening may be included in the study:
-
Are between ≥ 18 years and ≤ 85 years at the signing of informed consent
-
Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening
-
Are receiving oral loop diuretics on a regular schedule
-
Patients without AFF on screening ECG:
- LVEF < 30% within 6 months of screening
- Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL)
-
Patients with AFF on screening ECG:
- LVEF < 25% within 6 months of screening
- Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL)
- Not currently taking digoxin
-
Meet one of the following criteria for a recent HF event:
- Are currently hospitalized with the primary reason of HF
- Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or
- Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic.
-
Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
-
Systolic blood pressure ≤ 140 mmHg
Exclusion Criteria:
Any of the following criteria will exclude potential patients from the study:
- Have AFF on the screening ECG and are currently taking digoxin
- Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and/or any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening
- Are admitted to a long-term care facility or hospice
- Have a projected survival of < 12 months due to non-cardiovascular causes based on clinical judgment
- Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening
- Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening
- Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure)
- Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receiving dialysis at screening
- Have previously had a solid organ transplant
- Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening
- Have received omecamtiv mecarbil in a previous clinical trial
- Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP
- Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Omecamtiv Mecarbil
Participants randomized to omecamtiv mecarbil will be dosed based on their omecamtiv mecarbil plasma concentration at 25, 37.5 or 50 mg twice daily until at least 850 participants experience a HF event or CV death, whichever comes first. |
Oral Tablet |
|
Placebo komparator: Placebo
Participants randomized to placebo will receive placebo twice daily until at least 850 participants experience a HF event or CV death, whichever comes first. |
Oral Tablet |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Efficacy of omecamtiv mecarbil compared with placebo on the risk of HF outcomes in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy per local standard of care. |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to the first event of CV death or HF event
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of CV death and HF event |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to the first HF hospitalization
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of HF hospitalization |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of HF outcomes in patients with severe HF, defined as patients with NYHA class 3-4 symptoms and a HF event within the last 3 months |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to the first event of CV death, LVAD implantation/cardiac transplantation, or stroke
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of irreversible morbidity/mortality related to HFrEF |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to CV death
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of CV mortality |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to first event of stroke
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of stroke |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to all-cause death
Tidsramme: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of all-cause mortality |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Cytokinetics MD, Cytokinetics
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. desember 2024
Primær fullføring (Antatt)
1. september 2027
Studiet fullført (Antatt)
1. desember 2027
Datoer for studieregistrering
Først innsendt
3. desember 2024
Først innsendt som oppfylte QC-kriteriene
13. desember 2024
Først lagt ut (Faktiske)
16. desember 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. oktober 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CY 1033
- 2024-519219-32-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .