Undersøgelse med Omecamtiv Mecarbil (CK-1827452) til behandling af kronisk hjertesvigt med alvorligt reduceret ejektionsfraktion (COMET-HF)
7. oktober 2026 opdateret af: Cytokinetics
Et multicenter, dobbeltblindt, randomiseret, placebokontrolleret forsøg til vurdering af effektivitet og sikkerhed af Omecamtiv Mecarbil hos patienter med symptomatisk hjertesvigt med alvorligt reduceret 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.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1800
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Cytokinetics MD
- Telefonnummer: (650) 624-2929
- E-mail: medicalaffairs@cytokinetics.com
Studiesteder
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Alberta
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Edmonton, Alberta, Canada, T6G2B7
- Rekruttering
- 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
- Trukket tilbage
- Diex Recherche Sherbrooke
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Terrebonne, Quebec, Canada, J6V 2H2
- Rekruttering
- CISSSL - Hopital Pierre-Le Gardeur
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Basingstoke, Det Forenede Kongerige, RG249NA
- Rekruttering
- Basingstoke and North Hampshire Hospital
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Cottingham, Det Forenede Kongerige, HU165JQ
- Rekruttering
- Castle Hill Hospital
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Dudley, Det Forenede Kongerige, DY12HQ
- Rekruttering
- Russells Hall Hospital
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Dundonald, Det Forenede Kongerige, BT161RH
- Rekruttering
- Ulster Hospital
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Glasgow, Det Forenede Kongerige, G40SF
- Rekruttering
- Glasgow Royal Infirmary
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Swindon, Det Forenede Kongerige, SN36BB
- Rekruttering
- Great Western Hospitals
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Greater London
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Harefield, Greater London, Det Forenede Kongerige, UB96JH
- Rekruttering
- Harefield Hospital
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Hampshire
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Southampton, Hampshire, Det Forenede Kongerige, SO166YD
- Rekruttering
- Southampton General Hospital
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Scotland
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Glasgow, Scotland, Det Forenede Kongerige, G514TF
- Rekruttering
- Queen Elizabeth University Hospital
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-
-
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Alabama
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Alexander City, Alabama, Forenede Stater, 35010
- Rekruttering
- Advanced Cardiovascular, LLC
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Birmingham, Alabama, Forenede Stater, 35233
- Rekruttering
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Forenede Stater, 85741
- Trukket tilbage
- Pima Heart and Vascular Clinical Research
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California
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Beverly Hills, California, Forenede Stater, 90211
- Rekruttering
- National Heart Institute
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La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Health - Sulpizio Cardiovascular Center
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Loma Linda, California, Forenede Stater, 92350
- Rekruttering
- Nutrition Research Center (SPH)
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Los Angeles, California, Forenede Stater, 90033
- Rekruttering
- Keck Medical Center of USC (outpatient clinic)
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- UCLA Medical Center Cardiovascular Clinic
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Orange, California, Forenede Stater, 92868
- Rekruttering
- University of California, Irvine Medical Center
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Sacramento, California, Forenede Stater, 95817
- Rekruttering
- UC Davis Health
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Sacramento, California, Forenede Stater, 95816
- Rekruttering
- Sutter Institute for Medical Research (SIMR)
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- San Diego Cardiac Center
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San Francisco, California, Forenede Stater, 94109
- Rekruttering
- California Pacific Medical Center Van Ness Campus
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Santa Clara, California, Forenede Stater, 95051
- Rekruttering
- Kaiser Permanente Santa Clara
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Stanford, California, Forenede Stater, 94303
- Rekruttering
- Stanford University Hospital / Stanford Health Care
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Torrance, California, Forenede Stater, 90502
- Rekruttering
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Rocky Mountain Regional VA Medical Center
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06606
- Rekruttering
- Cardiology Associates of Fairfield County, P.C
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Hartford, Connecticut, Forenede Stater, 06102
- Rekruttering
- Hartford Hospital
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New Haven, Connecticut, Forenede Stater, 06519
- Rekruttering
- Yale New Haven Health Heart & Vascular Center Outpatient Services
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Florida
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Clearwater, Florida, Forenede Stater, 33756
- Rekruttering
- CHF Heart Clinical (Subject Visits & IP Shipments)
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Rekruttering
- Holy Cross Medical Group - Cardiology Associates
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Hollywood, Florida, Forenede Stater, 33351
- Rekruttering
- South Florida Research Solutions, LLC
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Jacksonville, Florida, Forenede Stater, 32209
- Rekruttering
- UF Health Jacksonville
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Miami Beach, Florida, Forenede Stater, 33140
- Rekruttering
- Broward Research Center
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Ocala, Florida, Forenede Stater, 34471
- Rekruttering
- Ocala Cardiovascular Research
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Orlando, Florida, Forenede Stater, 32803
- Rekruttering
- AdventHealth
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Tampa, Florida, Forenede Stater, 33606
- Rekruttering
- USF Health South Tampa Center for Advanced Healthcare
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Rekruttering
- Grady Health System
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory Clinic
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Atlanta, Georgia, Forenede Stater, 30309
- Rekruttering
- Piedmont Atlanta Hospital
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Fayetteville, Georgia, Forenede Stater, 30214
- Rekruttering
- Piedmont Fayette Hospital
-
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Rekruttering
- The Queen's Medical Center - Punchbowl
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Illinois
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Naperville, Illinois, Forenede Stater, 60540
- Rekruttering
- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, Forenede Stater, 46321
- Rekruttering
- Cardiovascular Research of Northwest Indiana, LLC.
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Newburgh, Indiana, Forenede Stater, 47630
- Rekruttering
- Deaconess Heart Group
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Richmond, Indiana, Forenede Stater, 47374
- Rekruttering
- Reid Physician Associates
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Rekruttering
- The University of Kansas Medical Center
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Overland Park, Kansas, Forenede Stater, 66211
- Rekruttering
- AHMG Cardiology and Surgery
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Rekruttering
- University Medical Center New Orleans
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Maine
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Bangor, Maine, Forenede 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, Forenede Stater, 21201
- Rekruttering
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Rekruttering
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Henry Ford Hospital
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Missouri
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Independence, Missouri, Forenede Stater, 64057
- Trukket tilbage
- Midwest Heart and Vascular Specialists, LLC
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Kansas City, Missouri, Forenede Stater, 64111
- Rekruttering
- Saint Luke's Hospital of Kansas City
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University Center for Advanced Medicine
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St Louis, Missouri, Forenede Stater, 63136
- Trukket tilbage
- St. Louis Heart and Vascular
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Rekruttering
- University of Nebraska Medical Center
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New Jersey
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Bridgewater, New Jersey, Forenede Stater, 08807
- Rekruttering
- Advanced Heart Care, LLC
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Eatontown, New Jersey, Forenede Stater, 07724
- Rekruttering
- Monmouth Cardiology Associates, LLC
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New York
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Albany, New York, Forenede Stater, 12205
- Rekruttering
- Capital Cardiology Associates
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Manhasset, New York, Forenede Stater, 11030
- Rekruttering
- Northwell Health North Shore University Hospital
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Mount Sinai Hospital
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New York, New York, Forenede Stater, 10032
- Rekruttering
- Columbia University Medical Center / New York - Presbyterian
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The Bronx, New York, Forenede Stater, 10467
- Rekruttering
- Montefiore Medical Center (Moses Campus)
-
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North Carolina
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Cary, North Carolina, Forenede Stater, 27518
- Rekruttering
- WakeMed Heart & Vascular - Cary Cardiology
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Chapel Hill, North Carolina, Forenede Stater, 27599-7064
- Rekruttering
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill
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Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Hospital
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Greensboro, North Carolina, Forenede Stater, 27401
- Rekruttering
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Rekruttering
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- The Lindner Research Center at the Christ Hospital
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic
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Marion, Ohio, Forenede Stater, 43302
- Trukket tilbage
- K&R Research LLC
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Sandusky, Ohio, Forenede Stater, 44870
- Trukket tilbage
- University of Hospitals North Ohio Heart
-
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74127
- Rekruttering
- Oklahoma State University Center for Health Sciences
-
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health and Science University
-
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Pennsylvania
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Camp Hill, Pennsylvania, Forenede Stater, 17011
- Rekruttering
- Capital Area Research, LLC
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Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede 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, Forenede 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, Forenede 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, Forenede Stater, 38138
- Rekruttering
- Stern Cardiovascular Foundation, Inc.
-
Knoxville, Tennessee, Forenede Stater, 37934
- Rekruttering
- Tennova Healthcare-Turkey Creek Medical Center
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
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Tullahoma, Tennessee, Forenede Stater, 37388
- Rekruttering
- Tennessee Center for Clinical Trials
-
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Baylor University Medical Center
-
Dallas, Texas, Forenede Stater, 75390
- Rekruttering
- The University of Texas Southwestern Medical Center
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El Paso, Texas, Forenede Stater, 79902
- Trukket tilbage
- Medresearch Inc
-
Galveston, Texas, Forenede Stater, 77555
- Rekruttering
- University of Texas Medical Branch - UTMB
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- CHI St. Luke's Health Baylor College of Medicine Medical Center
-
Plano, Texas, Forenede Stater, 75093
- Rekruttering
- Baylor Scott & White Medical Center- The Hearth Hospital
-
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Utah
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Murray, Utah, Forenede Stater, 84107
- Rekruttering
- Intermountain Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84132
- Rekruttering
- University of Utah Health
-
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Virginia
-
Norfolk, Virginia, Forenede Stater, 23507
- Trukket tilbage
- Sentara Norfolk General Hospital
-
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Washington
-
Spokane, Washington, Forenede Stater, 99204
- Rekruttering
- Providence Advanced Heart Disease and Transplant
-
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Medical College of Wisconsin / Froedtert Hospital
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-
-
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrig, 31059
- Rekruttering
- Centre Hospitalier Universitaire de Toulouse
-
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Hauts-de-France
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Valenciennes, Hauts-de-France, Frankrig, 59300
- Rekruttering
- Polyclinique Vauban
-
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrig, 35033
- Rekruttering
- CHU de Rennes - Hôpital Pontchaillou
-
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Isère
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La Tronche, Isère, Frankrig, 38700
- Rekruttering
- Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
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Occitanie
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Montpellier, Occitanie, Frankrig, 34295
- Rekruttering
- CHU de Montpellier- Hôpital Arnaud de Villeneuve
-
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Pays de la Loire Region
-
Nantes, Pays de la Loire Region, Frankrig, 44277
- Rekruttering
- L'Hôpital Privé Du Confluent
-
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Rhône
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Bron, Rhône, Frankrig, 69677
- Rekruttering
- Hospices Civils de Lyon - Hôpital Louis Pradel
-
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Var
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Toulon, Var, Frankrig, 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, Frankrig, 75010
- Rekruttering
- Hôpital Lariboisière - APHP
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Paris, Île-de-France Region, Frankrig, 75015
- Rekruttering
- Hôpital Européen Georges Pompidou
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Paris, Île-de-France Region, Frankrig, 75018
- Rekruttering
- APHP - Hôpital Bichât
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-
-
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Attica
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Athens, Attica, Grækenland, 11527
- Rekruttering
- General Hospital of Athens ''G. Gennimatas''
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Athens, Attica, Grækenland, 11527
- Rekruttering
- General Hospital of Athens ''Hippokratio''
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Athens, Attica, Grækenland, 14233
- Rekruttering
- General Hospital of Nea Ionia ''Konstantopouleio-Patision''
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Chaïdári, Attica, Grækenland, 12462
- Rekruttering
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H
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Voula, Attica, Grækenland, 16673
- Rekruttering
- General Hospital ''Asklepieio Voulas''
-
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Euboea
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Chalcis, Euboea, Grækenland, 34100
- Rekruttering
- General Hospital of Chalkida
-
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Evros
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Alexandroupoli, Evros, Grækenland, 68100
- Rekruttering
- University General Hospital of Alexandroupolis
-
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Larissa
-
Larissa, Larissa, Grækenland, 41110
- Rekruttering
- University General Hospital of Larissa
-
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Thessaloniki
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Efkarpia, Thessaloniki, Grækenland, 56403
- Rekruttering
- Papageorgiou General Hospital of Thessaloniki
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Thessaloniki, Thessaloniki, Grækenland, 54636
- Rekruttering
- AHEPA University General Hospital of Thessaloniki
-
-
-
-
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Cona, Italien, 44124
- Rekruttering
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
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Roma, Italien, 00163
- Rekruttering
- IRCCS San Raffaele
-
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BS
-
Brescia, BS, Italien, 25123
- Rekruttering
- ASST Spedali Civili di Brescia
-
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Emilia-Romagna
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Rimini, Emilia-Romagna, Italien, 47923
- Rekruttering
- Ospedale Infermi
-
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Lombardy
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Arzignano, Lombardy, Italien, 36071
- Rekruttering
- Ospedale di Arzignano
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Bergamo, Lombardy, Italien, 24127
- Rekruttering
- ASST Papa Giovanni XXIII
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Milan, Lombardy, Italien, 20138
- Rekruttering
- Centro Cardiologico Monzino
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Sesto San Giovanni, Lombardy, Italien, 20099
- Rekruttering
- IRCCS Multimedica
-
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MI
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Milan, MI, Italien, 20132
- Rekruttering
- IRCCS Ospedale San Raffaele
-
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Province of Perugia
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Perugia, Province of Perugia, Italien, 06129
- Rekruttering
- A.O. Perugia - Ospedale S.Maria della Misericordia
-
-
-
-
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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
-
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, Spanien, 15006
- Rekruttering
- Hospital Universitario A Coruña
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Santiago de Compostela, A Coruña, Spanien, 15706
- Rekruttering
- Hospital Clinico Universitario de Santiago
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Barcelona
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Barcelona, Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron
-
Barcelona, Barcelona, Spanien, 08025
- Rekruttering
- Hospital de la Santa Creu i Sant Pau
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Rekruttering
- Hospital Universitari de Bellvitge
-
-
Jaen
-
Úbeda, Jaen, Spanien, 23400
- Rekruttering
- Hospital San Juan de la Cruz
-
-
Lugo
-
Lugo, Lugo, Spanien, 27003
- Rekruttering
- Hospital Universitario Lucus Augusti
-
-
Madrid
-
Madrid, Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Madrid, Madrid, Spanien, 28046
- Rekruttering
- Hospital Universitario La Paz
-
Majadahonda, Madrid, Spanien, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro
-
-
Murcia
-
El Palmar, Murcia, Spanien, 30120
- Rekruttering
- Hospital Universitario Virgen de La Arrixaca
-
-
Pontevedra
-
Vigo, Pontevedra, Spanien, 36312
- Rekruttering
- CHUVI - H.U. Alvaro Cunqueiro
-
-
Salamanca
-
Salamanca, Salamanca, Spanien, 37007
- Rekruttering
- Hospital Universitario de Salamanca
-
-
Sevilla
-
Seville, Sevilla, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocío
-
-
Tarragona
-
Tarragona, Tarragona, Spanien, 43005
- Rekruttering
- Hospital Universitari Joan XXIII de Tarragona
-
-
Valencia
-
Valencia, Valencia, Spanien, 46010
- Rekruttering
- Hospital Clínico Universitario de Valencia
-
Valencia, Valencia, Spanien, 46026
- Rekruttering
- Hospital Universitari i Politecnic La Fe de Valencia
-
-
-
-
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
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Cytokinetics MD, Cytokinetics
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. december 2024
Primær færdiggørelse (Anslået)
1. september 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
3. december 2024
Først indsendt, der opfyldte QC-kriterier
13. december 2024
Først opslået (Faktiske)
16. december 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. oktober 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CY 1033
- 2024-519219-32-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .