Studie med Omecamtiv Mecarbil (CK-1827452) för att behandla kronisk hjärtsvikt med kraftigt reducerad ejektionsfraktion (COMET-HF)
2 november 2026 uppdaterad av: Cytokinetics
En multicenter, dubbelblind, randomiserad, placebokontrollerad studie för att bedöma effektivitet och säkerhet av Omecamtiv Mecarbil hos patienter med symtomatisk hjärtsvikt med kraftigt reducerad ejektionsfraktion (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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
1800
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Cytokinetics MD
- Telefonnummer: (650) 624-2929
- E-post: medicalaffairs@cytokinetics.com
Studieorter
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrike, 31059
- Rekrytering
- Centre Hospitalier Universitaire de Toulouse
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Hauts-de-France
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Valenciennes, Hauts-de-France, Frankrike, 59300
- Rekrytering
- Polyclinique Vauban
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35033
- Rekrytering
- CHU de Rennes - Hôpital Pontchaillou
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Isère
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La Tronche, Isère, Frankrike, 38700
- Rekrytering
- Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
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Occitanie
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Montpellier, Occitanie, Frankrike, 34295
- Rekrytering
- 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
- Rekrytering
- L'Hôpital Privé Du Confluent
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Rhône
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Bron, Rhône, Frankrike, 69677
- Rekrytering
- Hospices Civils de Lyon - Hôpital Louis Pradel
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Var
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Toulon, Var, Frankrike, 83100
- Rekrytering
- 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
- Rekrytering
- Hôpital Lariboisière - APHP
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Paris, Île-de-France Region, Frankrike, 75015
- Rekrytering
- Hôpital Européen Georges Pompidou
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Paris, Île-de-France Region, Frankrike, 75018
- Rekrytering
- APHP - Hôpital Bichât
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Alabama
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Alexander City, Alabama, Förenta staterna, 35010
- Rekrytering
- Advanced Cardiovascular, LLC
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Birmingham, Alabama, Förenta staterna, 35233
- Rekrytering
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Förenta staterna, 85741
- Indragen
- Pima Heart and Vascular Clinical Research
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California
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Beverly Hills, California, Förenta staterna, 90211
- Rekrytering
- National Heart Institute
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La Jolla, California, Förenta staterna, 92037
- Rekrytering
- UC San Diego Health - Sulpizio Cardiovascular Center
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Loma Linda, California, Förenta staterna, 92350
- Rekrytering
- Nutrition Research Center (SPH)
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Los Angeles, California, Förenta staterna, 90033
- Rekrytering
- Keck Medical Center of USC (outpatient clinic)
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Los Angeles, California, Förenta staterna, 90095
- Rekrytering
- UCLA Medical Center Cardiovascular Clinic
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Orange, California, Förenta staterna, 92868
- Rekrytering
- University of California, Irvine Medical Center
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Sacramento, California, Förenta staterna, 95817
- Rekrytering
- UC Davis Health
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Sacramento, California, Förenta staterna, 95816
- Rekrytering
- Sutter Institute for Medical Research (SIMR)
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San Diego, California, Förenta staterna, 92123
- Rekrytering
- San Diego Cardiac Center
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San Francisco, California, Förenta staterna, 94109
- Rekrytering
- California Pacific Medical Center Van Ness Campus
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Santa Clara, California, Förenta staterna, 95051
- Rekrytering
- Kaiser Permanente Santa Clara
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Stanford, California, Förenta staterna, 94303
- Rekrytering
- Stanford University Hospital / Stanford Health Care
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Torrance, California, Förenta staterna, 90502
- Rekrytering
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- Rocky Mountain Regional VA Medical Center
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Connecticut
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Bridgeport, Connecticut, Förenta staterna, 06606
- Rekrytering
- Cardiology Associates of Fairfield County, P.C
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Hartford, Connecticut, Förenta staterna, 06102
- Rekrytering
- Hartford Hospital
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New Haven, Connecticut, Förenta staterna, 06519
- Rekrytering
- Yale New Haven Health Heart & Vascular Center Outpatient Services
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Florida
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Clearwater, Florida, Förenta staterna, 33756
- Rekrytering
- CHF Heart Clinical (Subject Visits & IP Shipments)
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Fort Lauderdale, Florida, Förenta staterna, 33308
- Rekrytering
- Holy Cross Medical Group - Cardiology Associates
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Hollywood, Florida, Förenta staterna, 33351
- Rekrytering
- South Florida Research Solutions, LLC
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Jacksonville, Florida, Förenta staterna, 32209
- Rekrytering
- UF Health Jacksonville
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Miami Beach, Florida, Förenta staterna, 33140
- Rekrytering
- Broward Research Center
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Ocala, Florida, Förenta staterna, 34471
- Rekrytering
- Ocala Cardiovascular Research
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Orlando, Florida, Förenta staterna, 32803
- Rekrytering
- AdventHealth
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Tampa, Florida, Förenta staterna, 33606
- Rekrytering
- USF Health South Tampa Center for Advanced Healthcare
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Tampa, Florida, Förenta staterna, 33607
- Rekrytering
- Saint Josephs Hospitals
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Georgia
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Atlanta, Georgia, Förenta staterna, 30303
- Rekrytering
- Grady Health System
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Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Emory Clinic
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Atlanta, Georgia, Förenta staterna, 30309
- Rekrytering
- Piedmont Atlanta Hospital
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Fayetteville, Georgia, Förenta staterna, 30214
- Rekrytering
- Piedmont Fayette Hospital
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- Rekrytering
- The Queen's Medical Center - Punchbowl
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Illinois
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Naperville, Illinois, Förenta staterna, 60540
- Rekrytering
- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, Förenta staterna, 46321
- Rekrytering
- Cardiovascular Research of Northwest Indiana, LLC.
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Newburgh, Indiana, Förenta staterna, 47630
- Rekrytering
- Deaconess Heart Group
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Richmond, Indiana, Förenta staterna, 47374
- Rekrytering
- Reid Physician Associates
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- Rekrytering
- The University of Kansas Medical Center
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Overland Park, Kansas, Förenta staterna, 66211
- Rekrytering
- AHMG Cardiology and Surgery
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Rekrytering
- University Medical Center New Orleans
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Maine
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Bangor, Maine, Förenta staterna, 04401
- Rekrytering
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Rekrytering
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02111
- Rekrytering
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Rekrytering
- Henry Ford Hospital
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Missouri
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Independence, Missouri, Förenta staterna, 64057
- Indragen
- Midwest Heart and Vascular Specialists, LLC
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Kansas City, Missouri, Förenta staterna, 64111
- Rekrytering
- Saint Luke's Hospital of Kansas City
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St Louis, Missouri, Förenta staterna, 63110
- Rekrytering
- Washington University Center for Advanced Medicine
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St Louis, Missouri, Förenta staterna, 63136
- Indragen
- St. Louis Heart and Vascular
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68198
- Rekrytering
- University of Nebraska Medical Center
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New Jersey
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Bridgewater, New Jersey, Förenta staterna, 08807
- Rekrytering
- Advanced Heart Care, LLC
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Eatontown, New Jersey, Förenta staterna, 07724
- Rekrytering
- Monmouth Cardiology Associates, LLC
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New York
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Albany, New York, Förenta staterna, 12205
- Rekrytering
- Capital Cardiology Associates
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Manhasset, New York, Förenta staterna, 11030
- Rekrytering
- Northwell Health North Shore University Hospital
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New York, New York, Förenta staterna, 10029
- Rekrytering
- Mount Sinai Hospital
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New York, New York, Förenta staterna, 10032
- Rekrytering
- Columbia University Medical Center / New York - Presbyterian
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Poughkeepsie, New York, Förenta staterna, 12601
- Rekrytering
- Hudson Valley Cardiovascular Practice
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The Bronx, New York, Förenta staterna, 10467
- Rekrytering
- Montefiore Medical Center (Moses Campus)
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North Carolina
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Cary, North Carolina, Förenta staterna, 27518
- Rekrytering
- WakeMed Heart & Vascular - Cary Cardiology
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Chapel Hill, North Carolina, Förenta staterna, 27599-7064
- Rekrytering
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill
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Durham, North Carolina, Förenta staterna, 27710
- Rekrytering
- Duke University Hospital
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Greensboro, North Carolina, Förenta staterna, 27401
- Rekrytering
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Rekrytering
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- Rekrytering
- The Lindner Research Center at the Christ Hospital
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Cleveland, Ohio, Förenta staterna, 44106
- Rekrytering
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Förenta staterna, 44195
- Rekrytering
- Cleveland Clinic
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Marion, Ohio, Förenta staterna, 43302
- Indragen
- K&R Research LLC
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Sandusky, Ohio, Förenta staterna, 44870
- Indragen
- University of Hospitals North Ohio Heart
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Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74127
- Rekrytering
- Oklahoma State University Center for Health Sciences
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Rekrytering
- Oregon Health and Science University
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Pennsylvania
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Camp Hill, Pennsylvania, Förenta staterna, 17011
- Rekrytering
- Capital Area Research, LLC
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Hershey, Pennsylvania, Förenta staterna, 17033
- Rekrytering
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Rekrytering
- 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, Förenta staterna, 29425
- Rekrytering
- Medical University of South Carolina - Gazes Research Institute
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57701
- Rekrytering
- Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
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Tennessee
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Germantown, Tennessee, Förenta staterna, 38138
- Rekrytering
- Stern Cardiovascular Foundation, Inc.
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Knoxville, Tennessee, Förenta staterna, 37934
- Rekrytering
- Tennova Healthcare-Turkey Creek Medical Center
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Nashville, Tennessee, Förenta staterna, 37232
- Rekrytering
- Vanderbilt University Medical Center
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Tullahoma, Tennessee, Förenta staterna, 37388
- Rekrytering
- Tennessee Center for Clinical Trials
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Texas
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Dallas, Texas, Förenta staterna, 75246
- Rekrytering
- Baylor University Medical Center
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Dallas, Texas, Förenta staterna, 75390
- Rekrytering
- The University of Texas Southwestern Medical Center
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El Paso, Texas, Förenta staterna, 79902
- Indragen
- Medresearch Inc
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Galveston, Texas, Förenta staterna, 77555
- Rekrytering
- University of Texas Medical Branch - UTMB
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- CHI St. Luke's Health Baylor College of Medicine Medical Center
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Plano, Texas, Förenta staterna, 75093
- Rekrytering
- Baylor Scott & White Medical Center- The Hearth Hospital
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Utah
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Murray, Utah, Förenta staterna, 84107
- Rekrytering
- Intermountain Medical Center
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Salt Lake City, Utah, Förenta staterna, 84132
- Rekrytering
- University of Utah Health
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Virginia
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Norfolk, Virginia, Förenta staterna, 23507
- Indragen
- Sentara Norfolk General Hospital
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Washington
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Spokane, Washington, Förenta staterna, 99204
- Rekrytering
- Providence Advanced Heart Disease and Transplant
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Rekrytering
- Medical College of Wisconsin / Froedtert Hospital
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Attica
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Athens, Attica, Grekland, 11527
- Rekrytering
- General Hospital of Athens ''G. Gennimatas''
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Athens, Attica, Grekland, 11527
- Rekrytering
- General Hospital of Athens ''Hippokratio''
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Athens, Attica, Grekland, 14233
- Rekrytering
- General Hospital of Nea Ionia ''Konstantopouleio-Patision''
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Chaïdári, Attica, Grekland, 12462
- Rekrytering
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H
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Voula, Attica, Grekland, 16673
- Rekrytering
- General Hospital ''Asklepieio Voulas''
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Euboea
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Chalcis, Euboea, Grekland, 34100
- Rekrytering
- General Hospital of Chalkida
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Evros
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Alexandroupoli, Evros, Grekland, 68100
- Rekrytering
- University General Hospital of Alexandroupolis
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Larissa
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Larissa, Larissa, Grekland, 41110
- Rekrytering
- University General Hospital of Larissa
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Thessaloniki
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Efkarpia, Thessaloniki, Grekland, 56403
- Rekrytering
- Papageorgiou General Hospital of Thessaloniki
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Thessaloniki, Thessaloniki, Grekland, 54636
- Rekrytering
- AHEPA University General Hospital of Thessaloniki
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Cona, Italien, 44124
- Rekrytering
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
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Roma, Italien, 00163
- Rekrytering
- IRCCS San Raffaele
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BS
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Brescia, BS, Italien, 25123
- Rekrytering
- ASST Spedali Civili di Brescia
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Emilia-Romagna
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Rimini, Emilia-Romagna, Italien, 47923
- Rekrytering
- Ospedale Infermi
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Lombardy
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Arzignano, Lombardy, Italien, 36071
- Rekrytering
- Ospedale di Arzignano
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Bergamo, Lombardy, Italien, 24127
- Rekrytering
- ASST Papa Giovanni XXIII
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Milan, Lombardy, Italien, 20138
- Rekrytering
- Centro Cardiologico Monzino
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Sesto San Giovanni, Lombardy, Italien, 20099
- Rekrytering
- IRCCS Multimedica
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MI
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Milan, MI, Italien, 20132
- Rekrytering
- IRCCS Ospedale San Raffaele
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Province of Perugia
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Perugia, Province of Perugia, Italien, 06129
- Rekrytering
- A.O. Perugia - Ospedale S.Maria della Misericordia
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Alberta
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Edmonton, Alberta, Kanada, T6G2B7
- Rekrytering
- Mazankowski Alberta Heart Institute / University of Alberta Hospital
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y1T2
- Rekrytering
- Kelowna General Hospital
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Surrey, British Columbia, Kanada, V3V0C6
- Rekrytering
- SMH - Cardiology Clinical Trials Inc.
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Vancouver, British Columbia, Kanada, V6Z1Y6
- Rekrytering
- St. Paul's Hospital
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Victoria, British Columbia, Kanada, V8R1B2
- Rekrytering
- Victoria Heart Institute Foundation
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Manitoba
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Winnipeg, Manitoba, Kanada, R2H2A6
- Rekrytering
- St. Boniface Hospital
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Ontario
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Kingston, Ontario, Kanada, K7L 2V7
- Rekrytering
- Kingston Health Sciences Centre
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London, Ontario, Kanada, N6A5A5
- Rekrytering
- London Health Sciences Centre
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Oakville, Ontario, Kanada, L6M0L8
- Rekrytering
- Oakville Trafalgar Memorial Hospital - Halton Healthcare
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Toronto, Ontario, Kanada, M4N1J7
- Rekrytering
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Kanada, M5B1W8
- Rekrytering
- St. Michael's Hospital
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Toronto, Ontario, Kanada, M5G2C4
- Rekrytering
- UHN-Toronto General Hospital
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Quebec
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Montreal, Quebec, Kanada, H1T1C8
- Rekrytering
- Montreal Heart Institute
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Sherbrooke, Quebec, Kanada, J1L0H8
- Indragen
- Diex Recherche Sherbrooke
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Terrebonne, Quebec, Kanada, J6V 2H2
- Rekrytering
- CISSSL - Hopital Pierre-Le Gardeur
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-
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Haikou, Kina, 570311
- Rekrytering
- Hainan General Hospital
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Hengyang, Kina, 421001
- Rekrytering
- The First Affiliated Hospital of University of South China
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100032
- Rekrytering
- Peking University Third Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400014
- Rekrytering
- Chongqing Emergency Medical Center
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Gansu
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Lanzhou, Gansu, Kina, 730030
- Rekrytering
- Lanzhou University Second
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Guangdong
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Guangzhou, Guangdong, Kina, 511400
- Rekrytering
- The Affiliated Panyu Central Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, Kina, 510120
- Rekrytering
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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Shenzhen, Guangdong, Kina, 518053
- Rekrytering
- The University of Hong Kong-Shenzhen Hospital
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Guangxi
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Nanning, Guangxi, Kina, 530020
- Rekrytering
- The First Affiliated Hospital of Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150001
- Rekrytering
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Luoyang, Henan, Kina, 471031
- Rekrytering
- The First Affiliated Hospital of Henan University of science and Technology
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Zhengzhou, Henan, Kina, 450052
- Rekrytering
- The First Affiliated Hospital of Zhengzhou University
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Hunan
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Changsha, Hunan, Kina, 410011
- Rekrytering
- People's Hospital of Hunan Province
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Inner Mongolia
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Chifeng, Inner Mongolia, Kina, 024005
- Rekrytering
- Affiliated Hospital of Chifeng University
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Jiangsu
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Xuzhou, Jiangsu, Kina, 221002
- Rekrytering
- The Affiliated Hospital of Xuzhou Medical University
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Yangzhou, Jiangsu, Kina, 225001
- Rekrytering
- Northern Jiangsu People's Hospital
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Jilin
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Changchun, Jilin, Kina, 130033
- Rekrytering
- China-Japan Union Hospital of Jilin University
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Shandong
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Heze, Shandong, Kina, 274002
- Rekrytering
- Heze Municipal Hospital
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Jining, Shandong, Kina, 272029
- Rekrytering
- Affiliated Hospital of Jining Medical University
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Shanxi
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Taiyuan, Shanxi, Kina, 030024
- Rekrytering
- Shanxi Cardiovascular Hospital
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Yuncheng, Shanxi, Kina, 44000
- Rekrytering
- Yuncheng Central Hospital
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Taizhou
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Linhai, Taizhou, Kina, 317000
- Rekrytering
- Zhejiang Province Taizhou Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300457
- Rekrytering
- Teda International Cardiovascular Hospital
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Tianjin, Tianjin Municipality, Kina, 300020
- Rekrytering
- Tianjin Medical University General Hospital
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-
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Bialystok, Polen, 15276
- Rekrytering
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Krakow, Polen, 31202
- Rekrytering
- Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
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Lodz, Polen, 90549
- Rekrytering
- SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
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Lodz, Polen, 92213
- Rekrytering
- SPZOZ Centralny Szpital Kliniczny UM w Lodzi
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Miechów, Polen, 32200
- Rekrytering
- Szpital Sw. Anny w Miechowie
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Opole, Polen, 45401
- Rekrytering
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznan, Polen, 61848
- Rekrytering
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Ruda Śląska, Polen, 41710
- Rekrytering
- Poradnia AKA-MED Centrum Sp. z o.o.
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Torun, Polen, 87100
- Rekrytering
- Wojewodzki Szpital Zespolony im. L. Rydygiera
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Świdnik, Polen, 21040
- Rekrytering
- Tomasz Blicharski Lubelskie Centrum Diagnostyczne
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 01249
- Rekrytering
- Balsammedica Sp. z o.o.
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Warsaw, Masovian Voivodeship, Polen, 02-097
- Rekrytering
- Centralny Szpital Kliniczny UCK WUM
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A Coruña
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A Coruña, A Coruña, Spanien, 15006
- Rekrytering
- Hospital Universitario A Coruña
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Santiago de Compostela, A Coruña, Spanien, 15706
- Rekrytering
- Hospital Clinico Universitario de Santiago
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Barcelona
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Barcelona, Barcelona, Spanien, 08035
- Rekrytering
- Hospital Universitari Vall d'Hebron
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Barcelona, Barcelona, Spanien, 08025
- Rekrytering
- Hospital de la Santa Creu i Sant Pau
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Rekrytering
- Hospital Universitari de Bellvitge
-
-
Jaen
-
Úbeda, Jaen, Spanien, 23400
- Rekrytering
- Hospital San Juan de la Cruz
-
-
Lugo
-
Lugo, Lugo, Spanien, 27003
- Rekrytering
- Hospital Universitario Lucus Augusti
-
-
Madrid
-
Madrid, Madrid, Spanien, 28041
- Rekrytering
- Hospital Universitario 12 de Octubre
-
Madrid, Madrid, Spanien, 28046
- Rekrytering
- Hospital Universitario La Paz
-
Majadahonda, Madrid, Spanien, 28222
- Rekrytering
- Hospital Universitario Puerta de Hierro
-
-
Murcia
-
El Palmar, Murcia, Spanien, 30120
- Rekrytering
- Hospital Universitario Virgen de La Arrixaca
-
-
Pontevedra
-
Vigo, Pontevedra, Spanien, 36312
- Rekrytering
- CHUVI - H.U. Alvaro Cunqueiro
-
-
Salamanca
-
Salamanca, Salamanca, Spanien, 37007
- Rekrytering
- Hospital Universitario de Salamanca
-
-
Sevilla
-
Seville, Sevilla, Spanien, 41013
- Rekrytering
- Hospital Universitario Virgen del Rocío
-
-
Tarragona
-
Tarragona, Tarragona, Spanien, 43005
- Rekrytering
- Hospital Universitari Joan XXIII de Tarragona
-
-
Valencia
-
Valencia, Valencia, Spanien, 46010
- Rekrytering
- Hospital Clínico Universitario de Valencia
-
Valencia, Valencia, Spanien, 46026
- Rekrytering
- Hospital Universitari i Politecnic La Fe de Valencia
-
-
-
-
-
Basingstoke, Storbritannien, RG249NA
- Rekrytering
- Basingstoke and North Hampshire Hospital
-
Cottingham, Storbritannien, HU165JQ
- Rekrytering
- Castle Hill Hospital
-
Dudley, Storbritannien, DY12HQ
- Rekrytering
- Russells Hall Hospital
-
Dundonald, Storbritannien, BT161RH
- Rekrytering
- Ulster Hospital
-
Glasgow, Storbritannien, G40SF
- Rekrytering
- Glasgow Royal Infirmary
-
Swindon, Storbritannien, SN36BB
- Rekrytering
- Great Western Hospitals
-
-
Greater London
-
Harefield, Greater London, Storbritannien, UB96JH
- Rekrytering
- Harefield Hospital
-
-
Hampshire
-
Southampton, Hampshire, Storbritannien, SO166YD
- Rekrytering
- Southampton General Hospital
-
-
Scotland
-
Glasgow, Scotland, Storbritannien, G514TF
- Rekrytering
- Queen Elizabeth University Hospital
-
-
-
-
Baden-Wurttemberg
-
Heidelberg, Baden-Wurttemberg, Tyskland, 69120
- Rekrytering
- Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
-
-
Bavaria
-
München, Bavaria, Tyskland, 81377
- Rekrytering
- LMU Klinikum - Medizinische Klinik und Poliklinik I
-
Würzburg, Bavaria, Tyskland, 97078
- Rekrytering
- Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz
-
-
Free and Hanseatic City of Hamburg
-
Hamburg, Free and Hanseatic City of Hamburg, Tyskland, 20246
- Rekrytering
- UKE, Klinik für Kardiologie
-
Hamburg, Free and Hanseatic City of Hamburg, Tyskland, 20246
- Rekrytering
- UKE, Klinik fur Kardiologie
-
-
Germany
-
Erfurt, Germany, Tyskland, 99089
- Rekrytering
- Helios Klinikum Erfurt GmbH
-
Jena, Germany, Tyskland, 07747
- Rekrytering
- Universitaetsklinikum Jena
-
Mainz, Germany, Tyskland, 55131
- Rekrytering
- Marienhaus Klinikum Mainz GmbH
-
-
Hesse
-
Bad Nauheim, Hesse, Tyskland, 61231
- Rekrytering
- Kerckhoff-Klinik GmbH
-
Frankfurt am Main, Hesse, Tyskland, 60590
- Rekrytering
- Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
-
Langen, Hesse, Tyskland, 63225
- Rekrytering
- Asklepios Klinik Langen-Seligenstadt GmbH
-
-
Lower Saxony
-
Göttingen, Lower Saxony, Tyskland, 37075
- Rekrytering
- Universitaetsmedizin Goettingen
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Tyskland, 53127
- Rekrytering
- Universitätsklinikum Bonn
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66424
- Rekrytering
- Uniklinikum Saarland
-
-
Saxony
-
Markkleeberg, Saxony, Tyskland, 04416
- Rekrytering
- Dr. med. Jens Taggeselle
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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-jämförare: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to the first event of CV death or HF event
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Cytokinetics MD, Cytokinetics
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 december 2024
Primärt slutförande (Beräknad)
1 september 2027
Avslutad studie (Beräknad)
1 december 2027
Studieregistreringsdatum
Först inskickad
3 december 2024
Först inskickad som uppfyllde QC-kriterierna
13 december 2024
Första postat (Faktisk)
16 december 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CY 1033
- 2024-519219-32-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .