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Randomiseret placebokontrolleret forsøg med FCM som behandling for hjertesvigt med jernmangel (HEART-FID)

24. april 2023 opdateret af: American Regent, Inc.

En randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at undersøge effektiviteten og sikkerheden af ​​Injectafer® (ferric carboxymaltose) som behandling af hjertesvigt med jernmangel

Det primære formål med denne undersøgelse er at bestemme effektiviteten og sikkerheden af ​​jernbehandling med intravenøs (IV) ferricarboxymaltose (FCM) i forhold til placebo i behandlingen af ​​deltagere i hjertesvigt med en reduceret ejektionsfraktion og med jernmangel

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et dobbeltblindt, multicenter, prospektivt, randomiseret, placebokontrolleret studie for at vurdere virkningerne af IV FCM sammenlignet med placebo på 12-måneders dødsraten, hospitalsindlæggelse for forværret hjertesvigt og 6-måneders ændring i 6 minutters gangtest (6MWT) distance for patienter med hjertesvigt med jernmangel.

Efter en indledende screeningsperiode på op til 28 dage vil kvalificerede deltagere blive stratificeret efter region og randomiseret i forholdet 1:1 til FCM eller placebo til behandling.

Indgivelse af undersøgelseslægemiddel vil finde sted på dag 0 og dag 7 (±2) som et ufortyndet langsomt IV-skub, med yderligere undersøgelsesbesøg planlagt med 3 måneders intervaller, og yderligere dosering administreret hver 6. måned efter behov. I en undergruppe af lokaliteter vil der blive udført et delstudie for at karakterisere serumfosfatniveauer over tid hos deltagere med hjertesvigt og jernmangel efter dosering med FCM. For alle deltagere vil hæmatologi, ferritin og transferrinmætning (TSAT) med passende sikkerhedsevalueringer for at bestemme yderligere behandling forekomme med 6 måneders mellemrum.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3065

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Adelaide, Australien, 5000
        • Royal Adelaide Hospital
      • Macquarie Park, Australien, 2109
        • Macquarie University - Clinical Trials Unit
      • New Lambton Heights, Australien, 2305
        • John Hunter Hospital
      • Richmond, Australien, 3121
        • Epworth HealthCare Clinical Trials
    • New South Wales
      • Liverpool, New South Wales, Australien, 1871
        • SWSLHD-Liverpool Hospital
    • Queensland
      • Birtinya, Queensland, Australien, 4575
        • Sunshine Coast University Hospital
      • Cairns, Queensland, Australien, 4870
        • Cairns Hospital
      • Chermside, Queensland, Australien, 4032
        • The Prince Charles Hospital
      • Milton, Queensland, Australien, 4064
        • Core Research Group
      • Southport, Queensland, Australien, 4215
        • Gold Coast University Hospital
    • South Australia
      • Adelaide, South Australia, Australien, 5011
        • The Queen Elizabeth Hospital
      • Ashford, South Australia, Australien, 5035
        • SA Heart
      • Bedford Park, South Australia, Australien, 5042
        • Flinders Medical Centre
      • Elizabeth Vale, South Australia, Australien, 5112
        • Lyell McEwin Hospital
    • Sydney
      • Darlinghurst, Sydney, Australien
        • Heart Lung Clinic
    • Tasmania
      • Hobart, Tasmania, Australien, 7000
        • Royal Hobart Hospital
  • Bulgarien
      • Blagoevgrad, Bulgarien, 2700
        • MHAT Puls
      • Gabrovo, Bulgarien, 5300
        • Multiprofile Hospital for Active Treatment: Department of cardiology
      • Haskovo, Bulgarien, 6304
        • MHAT Haskovo AD
      • Lom, Bulgarien, 3600
        • Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
      • Pleven, Bulgarien, 5800
        • Medical Center Medconsult Pleven OOD
      • Sevlievo, Bulgarien, 5400
        • МC Hipokrena
      • Sofia, Bulgarien, 1113
        • Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
      • Sofia, Bulgarien, 1202
        • Second Medical Center-Sofia, EEOD - Department of Cardiology
      • Sofia, Bulgarien, 1202
        • Second Multiprofile Hospital for Active Treatment
      • Sofia, Bulgarien, 1233
        • 5th City Hospital
      • Sofia, Bulgarien, 1233
        • National Multiprofile Transport Hospital Cardiology Clinic
      • Sofia, Bulgarien, 1510
        • Medical Center Hera EOOD - Office of Cardiology
      • Veliko Tarnovo, Bulgarien, 5002
        • Multiprofile Regional Hospital for Active Treatment
      • Velingrad, Bulgarien, 4600
        • Medical Center Velingrad 2017" EOOD, Office of Cardiology
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calbary
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T6L 6K3
        • South Edmonton Cardiology Consultants
      • Edmonton, Alberta, Canada
        • Royal Alexandria Hospital
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials
      • Surrey, British Columbia, Canada, V3V 0C6
        • SMH Cardiology Clinical Trials
      • Vancouver, British Columbia, Canada, V6E 1M7
        • St. Paul's Hospital
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Heart Institute Foundation
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • G.A. Research Associates, Ltd.
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Nova Scotia Health Authority
    • Ontario
      • Burlington, Ontario, Canada, L7R 1A4
        • Manna Research Inc., Burlington South
      • Cambridge, Ontario, Canada, N1R 6V6
        • Cambridge Cardiac Care Center
      • Cambridge, Ontario, Canada, N1R 7R1
        • Vizel Cardiac Research
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Center (LHSC)
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Sinai Health System - Mount Sinai Hospital
    • Quebec
      • Lévis, Quebec, Canada, G6V 4Z5
        • Clinique de Cardiologie de Levis
      • Montréal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC)
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
      • Saint-Georges, Quebec, Canada, G5Y 4T8
        • CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
      • Saint-Jérôme, Quebec, Canada, J7Z 5T3
        • Recherche Medical St-Jerome Inc.
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation, 454017
        • Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
      • Chelyabinsk, Den Russiske Føderation, 454017
        • Municipal Autonomous Healthcare Institution
      • Kemerovo, Den Russiske Føderation, 650002
        • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
      • Moscow, Den Russiske Føderation, 117292
        • State Budgetary Healthcare Institution of Moscow city "Moscow
      • Pushkin, Den Russiske Føderation, 196603
        • Private Medical Institution "Euromedservice
      • Ryazan, Den Russiske Føderation, 390026
        • State Budgetary Institution of Ryazan Region
      • Saint Petersburg, Den Russiske Føderation, 190013
        • JSC Polyclinic Complex
      • Saint Petersburg, Den Russiske Føderation, 195257
        • Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
      • Saint Petersburg, Den Russiske Føderation, 196143
        • LLC "Scientific Research Center Eco-Safety"
      • Saint-Petersburg, Den Russiske Føderation, 190013
        • JSC Polyclinic Complex
      • Saratov, Den Russiske Føderation, 410002
        • State Healthcare Institution
      • Saratov, Den Russiske Føderation, 410054
        • Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
      • St. Petersburg, Den Russiske Føderation, 192242
        • Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
      • St. Petersburg, Den Russiske Føderation, 192242
        • Saint Petersburg Research Institute of Emergency Medicine
      • St. Petersburg, Den Russiske Føderation, 194156
        • LLC X7 Clinical Research
  • Forenede Stater
    • Alabama
      • Alexander City, Alabama, Forenede Stater, 35010
        • Advanced Cardiovascular LLC
      • Auburn, Alabama, Forenede Stater, 36830
        • Advanced Cardiovascular, LLC
      • Mobile, Alabama, Forenede Stater, 36617
        • University of South Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • IMC/Diagnostic & Medical Clinic
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Heart & Vascular Institute
    • Arizona
      • Cottonwood, Arizona, Forenede Stater, 86326
        • Verde Valley Medical Center
      • Surprise, Arizona, Forenede Stater, 85374
        • Clinical Research Institute of Arizona, LLC
      • Tucson, Arizona, Forenede Stater, 85710
        • Carondelet Heart and Vascular Institute - Cardiology East
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72901
        • Sparks Regional Medical Center
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • NEA Baptist Clinic
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Arkansas Heart Hospital
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Westside Medical Associates of Los Angeles
      • Carson, California, Forenede Stater, 90509
        • Harbor-UCLA Medical Center
      • Covina, California, Forenede Stater, 91723
        • Valley Clinical Trials, Inc.
      • El Cajon, California, Forenede Stater, 92020
        • TriWest Research Associates, LLC
      • Huntington Beach, California, Forenede Stater, 92648
        • California Heart Specialists
      • Lancaster, California, Forenede Stater, 93534
        • First Valley Medical Group
      • Long Beach, California, Forenede Stater, 90806
        • Healthcare Partners Affiliation Medical Group
      • Los Angeles, California, Forenede Stater, 90036
        • Axis Clinical Trials
      • Mission Viejo, California, Forenede Stater, 92691
        • St. Joseph Heritage-Healthcare
      • Newport Beach, California, Forenede Stater, 92663
        • Radin Cardiovascular Medical Group, Inc.
      • Northridge, California, Forenede Stater, 91325
        • Valley Clinical Trials, Inc.
      • Pasadena, California, Forenede Stater, 91105
        • Pasadena Clinical Research
      • Port Hueneme, California, Forenede Stater, 93041
        • Eugene Soroka, MD Inc.
      • San Diego, California, Forenede Stater, 92161
        • VA San Diego Health Care System
      • West Hills, California, Forenede Stater, 91307
        • Interventional Cardiology Medical Group
    • Colorado
      • Littleton, Colorado, Forenede Stater, 80120
        • South Denver Cardiology Associates, PC
    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
        • Danbury Hospital
      • Stamford, Connecticut, Forenede Stater, 06904
        • Stamford Hospital
    • Delaware
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Care
      • Wilmington, Delaware, Forenede Stater, 19803
        • Alfieri Cardiology
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Cardiology Associates of South Florida
      • Bradenton, Florida, Forenede Stater, 34209
        • Cardiovascular & Vein Center of Florida
      • Clearwater, Florida, Forenede Stater, 33756
        • Innovative Research of West Florida, Inc.
      • DeLand, Florida, Forenede Stater, 32720
        • Avail Clinical Research, LLC
      • Edgewater, Florida, Forenede Stater, 32132
        • Riverside Clinical Research
      • Hollywood, Florida, Forenede Stater, 33021
        • Memorial Regional Hospital
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic Florida
      • Jacksonville, Florida, Forenede Stater, 32209
        • Uf Health Jacksonville
      • Jacksonville, Florida, Forenede Stater, 32204
        • St. Vincent's Healthcare - Riverside
      • Jacksonville, Florida, Forenede Stater, 32216
        • St. Vincent's Healthcare - Southside Recruiting
      • Miami, Florida, Forenede Stater, 33165
        • Med-Care Research
      • Miami, Florida, Forenede Stater, 33176
        • Vista Health Research
      • Miami, Florida, Forenede Stater, 33130
        • ProLive Medical Research
      • Miami, Florida, Forenede Stater, 33155
        • Cordova Research Institute, LLC
      • Miami, Florida, Forenede Stater, 33173
        • ITB Research
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Empire Clinical Research, LLC
      • Orlando, Florida, Forenede Stater, 32804
        • Florida Hospital Transplant Institute
      • Palm Beach Gardens, Florida, Forenede Stater, 33410
        • Cardiology Partners Clinical Research Institute
      • Panama City, Florida, Forenede Stater, 32401
        • Springfield Medical Center
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • Broward Research Center
      • Pembroke Pines, Florida, Forenede Stater, 33026
        • South Florida Research Solutions, LLC
      • Pensacola, Florida, Forenede Stater, 32503
        • Avanza Medical Research Center
      • Pensacola, Florida, Forenede Stater, 32501
        • Cardiology Consultants
      • Saint Petersburg, Florida, Forenede Stater, 33713
        • Professional Health Care of Pinellas
      • Vero Beach, Florida, Forenede Stater, 32960
        • Indian River Medical Center
      • Wellington, Florida, Forenede Stater, 33449
        • Cardiology Partners Clinical Research Institute
    • Georgia
      • Athens, Georgia, Forenede Stater, 30606
        • Piedmont Heart Institute - Athens
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Heart Institute
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University
      • Augusta, Georgia, Forenede Stater, 30901
        • University Cardiology Associates, LLC
      • Fayetteville, Georgia, Forenede Stater, 30214
        • Piedmont Heart Institute Fayetteville
      • Macon, Georgia, Forenede Stater, 31201
        • Georgia Arrhythmia Consultants and Research Institute
      • Macon, Georgia, Forenede Stater, 31201
        • Mercer University
      • Smyrna, Georgia, Forenede Stater, 30082
        • Atlanta Vanguard Research Institute
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Saint Luke's Boise Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60608
        • Mount Sinai Hospital Medical Center - Department of Cardiology
      • Fairview Heights, Illinois, Forenede Stater, 62208
        • Medicoricium, LLC
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Parkview Research Center
      • Indianapolis, Indiana, Forenede Stater, 46237
        • Franciscan Physician Network - Indiana Heart Physicians
      • Indianapolis, Indiana, Forenede Stater, 46260
        • St. Vincent Medical Group
      • Muncie, Indiana, Forenede Stater, 47303
        • Indiana University Health Ball Memorial Hospital, Inc.
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Physician Associates / Reid Health
      • South Bend, Indiana, Forenede Stater, 46601
        • Beacon Medical Group Advanced Cardiovascular Specialists
    • Louisiana
      • Alexandria, Louisiana, Forenede Stater, 71301
        • Alexandria Cardiology Clinic
      • Hammond, Louisiana, Forenede Stater, 70403
        • Heart Clinic of Hammond
      • Houma, Louisiana, Forenede Stater, 70360
        • Cardiovascular Institute of the South
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Health System
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Heart & Vascular Institute
      • Slidell, Louisiana, Forenede Stater, 70458
        • Louisiana Heart Center
    • Maine
      • Scarborough, Maine, Forenede Stater, 04074
        • Maine Medical Partners Maine Health Cardiology
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Anne Arundel Health System Research Institute
      • Baltimore, Maryland, Forenede Stater, 21215
        • Sinai Hospital of Baltimore
      • Bethesda, Maryland, Forenede Stater, 20814
        • Suburban Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Fall River, Massachusetts, Forenede Stater, 02721
        • NECCR Prima Care Research, LLC
    • Michigan
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Genesys Regional Medical Center
      • Kalamazoo, Michigan, Forenede Stater, 49008
        • Western Michigan University Homer Stryker M.D. School of Medicine
      • Saginaw, Michigan, Forenede Stater, 48602
        • Michigan CardioVascular Institute at Covenant Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Allina Health System, dba Abbott Northwestern Hospital
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Cardiology Associates Research, LLC
    • Missouri
      • North Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Saint Louis, Missouri, Forenede Stater, 63136
        • St. Louis Heart & Vascular, PC
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68526
        • Nebraska Heart Institute
      • Omaha, Nebraska, Forenede Stater, 68124
        • CHI Health Research Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89146
        • Red Rock Clinical Research, LLC
    • New Jersey
      • Eatontown, New Jersey, Forenede Stater, 07724
        • Monmouth Cardiology Associates, LLC
      • Englewood, New Jersey, Forenede Stater, 07631
        • Englewood Health
      • Flemington, New Jersey, Forenede Stater, 08822
        • Advanced Heart & Vascular Institute of Hunterdon
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Saint Peter's University Hospital
      • Newark, New Jersey, Forenede Stater, 07102
        • Saint Michael's Medical Center
      • Newark, New Jersey, Forenede Stater, 07103
        • Rutgers New Jersey Medical School
      • Pomona, New Jersey, Forenede Stater, 08240
        • Atlanticare Regional Medical Center
      • Ridgewood, New Jersey, Forenede Stater, 07450
        • The Valley Hospital
      • Somerset, New Jersey, Forenede Stater, 08873
        • Cardio Metabolic Institute
      • Teaneck, New Jersey, Forenede Stater, 07666
        • Holy Name Medical Center
    • New York
      • Brooklyn, New York, Forenede Stater, 11215
        • New York Presbyterian Brooklyn Methodist Hospital
      • Cheektowaga, New York, Forenede Stater, 14227
        • Trinity Medical WNY, PC
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital
      • Rochester, New York, Forenede Stater, 14621
        • Rochester General Hospital
      • Staten Island, New York, Forenede Stater, 10310
        • Richmond University Medical Center
      • Stony Brook, New York, Forenede Stater, 11794-7007
        • Stony Brook University Hospital
      • West Seneca, New York, Forenede Stater, 14224
        • Circuit Clinical
      • Williamsville, New York, Forenede Stater, 14221
        • Northtowns Cardiology, PLLC
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28803
        • Asheville Cardiology Associates
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Heart Failure Research
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Medication Management, LLC
      • High Point, North Carolina, Forenede Stater, 27262
        • Wake Forest University Health Sciences
      • Lumberton, North Carolina, Forenede Stater, 28358
        • Duke Cardiology of Lumberton
      • Monroe, North Carolina, Forenede Stater, 28112
        • Monroe Biomedical Research
      • Mooresville, North Carolina, Forenede Stater, 28117
        • Crossroads Clinical Research, Inc.
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Pinehurst Medical Clinic, Inc.
      • Raleigh, North Carolina, Forenede Stater, 27610
        • WakeMed Health and Hospitals
      • Raleigh, North Carolina, Forenede Stater, 27607
        • NC Heart & Vascular Research
      • Wilmington, North Carolina, Forenede Stater, 28401
        • PMG Research of Wilmington
    • North Dakota
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Health Center - Medical Arts
    • Ohio
      • Canton, Ohio, Forenede Stater, 44710
        • Aultman Cardiology Clinical Trials
      • Cleveland, Ohio, Forenede Stater, 44109
        • The MetroHealth System
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University
      • Elyria, Ohio, Forenede Stater, 44035
        • North Ohio Heart Center
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Ohio Heart Center
      • Springfield, Ohio, Forenede Stater, 45505
        • Heart House Research Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73135
        • South Oklahoma Heart Research, LLC
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Abington Memorial Hospital
      • Camp Hill, Pennsylvania, Forenede Stater, 17011
        • Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
      • Lancaster, Pennsylvania, Forenede Stater, 17602
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19102
        • Drexel University
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania - Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, Forenede Stater, 15240
        • V.A. Pittsburgh Healthcare System
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Prisma Health
      • Greenwood, South Carolina, Forenede Stater, 29646
        • Self Regional Hospital Research Center
      • Lancaster, South Carolina, Forenede Stater, 29720
        • Carolina Heart Specialists
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Stern Cardiovascular Foundation
      • Knoxville, Tennessee, Forenede Stater, 37934
        • Tennova Healthcare-Turkey Creek Medical Center
      • Oak Ridge, Tennessee, Forenede Stater, 37830
        • Parkway Cardiology Associates, PC
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Amarillo Hearth Clinical Research Institute, Inc.
      • Amarillo, Texas, Forenede Stater, 79106
        • PharmaTex Research
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor University Medical Center
      • Dallas, Texas, Forenede Stater, 75216
        • Dallas VA Medical Center
      • Dallas, Texas, Forenede Stater, 75231
        • Cardiovascular Research Institute of Dallas
      • Dallas, Texas, Forenede Stater, 75235
        • Southwest Family Medicine Associates
      • Fort Worth, Texas, Forenede Stater, 76104
        • Texas Health Research & Education Institute
      • Houston, Texas, Forenede Stater, 77030
        • Texas Heart Institute
      • Kingwood, Texas, Forenede Stater, 77339
        • Houston Heart & Vascular Associates
      • Lubbock, Texas, Forenede Stater, 79410
        • Caprock Cardiac Center Research Institute, Inc.
      • Lufkin, Texas, Forenede Stater, 75904
        • Angelina Medical Research, LLC
      • McKinney, Texas, Forenede Stater, 75069
        • North Dallas Research Associates
      • McKinney, Texas, Forenede Stater, 75701
        • North Texas Research Associates
      • San Antonio, Texas, Forenede Stater, 78201
        • South Texas Cardiovascular Consultants, PLLC
      • Temple, Texas, Forenede Stater, 76508
        • Baylor Scott & White Medical Center
      • Tyler, Texas, Forenede Stater, 75708
        • The University of Texas Health Center at Tyler
      • Tyler, Texas, Forenede Stater, 75701
        • PharmaTex Research
      • Wichita Falls, Texas, Forenede Stater, 76301
        • Wichita Falls Heart Clinic
    • Utah
      • West Jordan, Utah, Forenede Stater, 84088
        • Advanced Clinical Research/Intermountain Heart Center PC
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • The University of Vermont Medical Center
    • Virginia
      • Lynchburg, Virginia, Forenede Stater, 24501
        • Stroobants Cardiovascular Center
      • Newport News, Virginia, Forenede Stater, 23601
        • Riverside Cardiology Specialists
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, Forenede Stater, 23298
        • VCU Medical Center
      • Richmond, Virginia, Forenede Stater, 23249
        • Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
      • Roanoke, Virginia, Forenede Stater, 24014
        • Carilion Medical Center
      • Winchester, Virginia, Forenede Stater, 22601
        • Selma Medical Associates
    • Washington
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Medical Center Everett
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish Heart & Vascular-Advanced Cardiac Support Program
      • Spokane, Washington, Forenede Stater, 99204
        • Providence Sacred Heart Medical Center & Children's Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • CHI Franciscan Research Center
      • Walla Walla, Washington, Forenede Stater, 99362
        • Walla Walla Clinic
      • Wenatchee, Washington, Forenede Stater, 98801
        • Wenatchee Valley Hospital & Clinics
    • Wisconsin
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College Of Wisconsin
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • ProHealth Care Inc / Waukesha Memorial Hospital
  • Georgien
      • Batumi, Georgien, 6010
        • JSC Evex Hospitals,Georgia
      • Kutaisi, Georgien, 4600
        • Clinic-LJ
      • Tbilisi, Georgien, 0159
        • Bokhua Memorial Cardiovascular Center
      • Tbilisi, Georgien, 0159
        • Tbilisi Heart and Vascular Clinic
      • Tbilisi, Georgien, 0102
        • Aleksandre Aladashvili Clinic LLC
      • Tbilisi, Georgien, 0112
        • Ltd Israel-Georgian Medical Research Clinic "Helsicore"
      • Tbilisi, Georgien, 0114
        • Ltd Pineo Medical Ecosistem
      • Tbilisi, Georgien, 0159
        • Acad. G. Chapidze Emergency Cardiology Center
      • Tbilisi, Georgien, 0160
        • Ltd TIM- Tbilisi Institute of Medicine
      • Tbilisi, Georgien, 0172
        • Georgian-Dutch Hospital
  • Letland
      • Daugavpils, Letland, LV5417
        • Daugavpils Regional Hospital
      • Liepaja, Letland, LV3414
        • Liepajas Regional Hospital
      • Riga, Letland, LV1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Letland, LV1038
        • Riga East University hospital clinic Gailezers
  • Litauen
      • Kaunas, Litauen, 50161
        • The Hospital of Lithuanian
      • Klaipėda, Litauen, 92288
        • Klaipeda Seaman's Hospital
      • Vilnius, Litauen, 08661
        • Vilnius University hospital Santaros klinikos
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Auckland, New Zealand, 2025
        • Middlemore Hospital
      • Auckland, New Zealand, 0622
        • North Shore Hospital
      • Auckland, New Zealand, 0600
        • Totara Clinical Research, Health New Lynn
      • Christchurch, New Zealand, 8140
        • Christchurch Heart Institute
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Gisborne, New Zealand, 4010
        • Hauora Tairāwhiti Department of Cardiology
      • Hastings, New Zealand, 4120
        • Hawke's Bay Hospital
      • Lower Hutt, New Zealand, 5010
        • Hutt Hospital
      • Nelson, New Zealand, 7010
        • Nelson Hospital
      • New Plymouth, New Zealand, 4310
        • Taranaki Base Hospital
      • Rotorua, New Zealand
        • Rotorua Hospital
      • Tauranga, New Zealand, 3112
        • Clinical Horizons NEW ZEALAND LTD
    • Wellington
      • Newton, Wellington, New Zealand, 6021
        • Wellington Hospital
  • Polen
      • Bytom, Polen, 41-902
        • Oddział Kardiologii WSzS nr 4
      • Józefów, Polen, 05-410
        • Biokinetica S.A. Przychodnia Józefów
      • Kraków, Polen, 30-394
        • Centrum Medyczne Linden
      • Lublin, Polen, 20-049
        • 1 Wojskowy Szpital Klininiczny w Lublinie
      • Lublin, Polen, 20-362
        • KO-MED Centra Kliniczne
      • Miechów, Polen, 32-200
        • Szpital Swietej Anny w Miechowie
      • Nowy Dwór Mazowiecki, Polen, 05-100
        • Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
      • Oława, Polen, 55-200
        • Zespol Opieki Zdrowotnej
      • Toruń, Polen, 87-100
        • Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
      • Warszawa, Polen, 02-097
        • Uniwersyteckie Centrum Kliniczne
      • Wołomin, Polen, 05-200
        • Centrum Medyczne K2J2
      • Wrocław, Polen, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
      • Wrocław, Polen, 50-981
        • 4th Military Hospital
      • Wrocław, Polen, 53-428
        • Proximum Centrum Usług Medycznych NZOZ
      • Łódź, Polen, 94-048
        • Marcin Ogórek, MD, PhD
  • Tjekkiet
      • Brno, Tjekkiet, 625 00
        • Interni kardiologicka klinika FN Brno
      • Chlumec Nad Cidlinou, Tjekkiet, 50353
        • Kardiologicka ambulance
      • Prague, Tjekkiet, 128 08
        • Centrum preventivní kardiologie, Karlovo nám. 32,
      • Prague, Tjekkiet, 128 08
        • Centrum preventivní kardiologie
      • Prague, Tjekkiet, 128 08
        • General University Hospital in Prague
      • Prague, Tjekkiet, 128 08
        • General University Hospital
      • Prague, Tjekkiet, 140 21
        • IKEM-Klinika kardiologie
  • Ukraine
      • Ivano-Frankivs'k, Ukraine, 76025
        • Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
      • Kharkiv, Ukraine, 61058
        • Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
      • Kharkiv, Ukraine, 61157
        • Scientific Medical Complex "University Clinic" of Kharkiv
      • Kharkiv, Ukraine, 61176
        • MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
      • Kryvyi Rih, Ukraine, 50031
        • Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
      • Kyiv, Ukraine, 01103
        • Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
      • Kyiv, Ukraine, 01601
        • Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
      • Kyiv, Ukraine, 02091
        • Communal non-profit enterprise Kyiv City Clinical Hospital №1
      • Kyiv, Ukraine, 02166
        • Kyiv City Clinical Hospital of Emergency Aid,
      • Kyiv, Ukraine, 02166
        • Kyiv City Clinical Hospital of Emergency Aid
      • Kyiv, Ukraine, 03049
        • Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
      • Kyiv, Ukraine, 03680
        • National Scientific Center Institute of Cardiology of M.D
      • Kyiv, Ukraine, 03680
        • State Institution "National Scientific Center "Institute of Cardiology
      • Kyiv, Ukraine, 04050
        • Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
      • Kyiv, Ukraine, 04050
        • Medical Centre of LLC
      • Kyiv,, Ukraine, 01601
        • "Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
      • Lviv, Ukraine, 79000
        • MNPE "Lviv City Clinical Hospital No.5"
      • Lviv, Ukraine, 79041
        • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia Regional Clinical Hospital of Veterans of War
      • Vinnytsia, Ukraine, 21029
        • "Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"
      • Zaporizhzhia, Ukraine, 69001
        • Communal Non-Profit Enterprise "City
      • Zaporizhzhia, Ukraine, 69063
        • Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
      • Zaporizhzhia, Ukraine, 69600
        • Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
      • Zhytomyr, Ukraine, 10002
        • Communal Enterprise "Hospital №1" of Zhytomyr City Council
  • Ungarn
      • Budapest, Ungarn, 1122
        • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
      • Budapest, Ungarn, 1085
        • Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
      • Gyöngyös, Ungarn, 3200
        • Clinexpert Gyöngyös Kft
      • Harkány, Ungarn, 7815
        • Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
      • Kecskemet, Ungarn, 6000
        • Bács-Kiskun Megyei Kórház Kardiológiai Osztály
      • Miskolc, Ungarn, 3529
        • Andrea Hornyik, MD
      • Pecs, Ungarn, 7624
        • Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
      • Szolnok, Ungarn, 5000
        • Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
      • Zalaegerszeg, Ungarn, 8900
        • Belvarosi Egeszseghaz Kft

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

16 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Voksen (≥18 år) kan give underskrevet, skriftligt informeret samtykke.
  2. Stabil hjertesvigt (NYHA II-IV) på maksimalt tolereret baggrundsterapi (som bestemt af webstedets principielle efterforsker) i mindst 2 uger før randomisering.
  3. I stand til og villig til at udføre en 6MWT på tidspunktet for randomisering.

  4. Reduceret venstre ventrikulær ejektionsfraktion. Vurdering skal udføres mindst 12 uger efter større hjertekirurgisk indgreb, herunder koronararterie-bypassgraft (CABG), klapreparation/-udskiftning eller implantation af enheden til hjerteresynkroniseringsterapi (CRT).

    en. Venstre ventrikel ejektionsfraktion ≤ 40 % opnået under screeningsbesøget ELLER en af ​​følgende i. Historisk værdi af ejektionsfraktion ≤ 40 % inden for 24 måneder efter screeningsbesøg ii. Historisk værdi af ejektionsfraktion ≤ 30 % inden for 36 måneder efter screeningsbesøg

  5. Hæmoglobin >9,0 g/dL og < 13,5 g/dL (hun) eller
  6. Serum ferritin
  7. Enten dokumenteret hospitalsindlæggelse for hjertesvigt inden for 12 måneder efter indskrivning eller forhøjet N-terminal-pro-brain natriuretisk peptid (NT-proBNP) inden for 90 dage efter randomisering. en. Til patienter i normal sinusrytme: N-terminal-pro-hjerne-natriuretisk peptid (NT-proBNP) > 600 pg/mL (eller BNP >200 pg/mL). b . Til patienter i atrieflimren: NT-proBNP >1000 pg/ml (eller BNP >400 pg/ml) .

Ekskluderingskriterier:

  1. Kendt overfølsomhedsreaktion over for enhver komponent i FCM.
  2. Anamnese med erhvervet jernoverskud eller nylig modtagelse (inden for 3 måneder) af erythropoietinstimulerende middel, IV jernbehandling eller blodtransfusion.
  3. Akut myokardieinfarkt, akut koronarsyndrom, forbigående iskæmisk anfald eller slagtilfælde inden for 30 dage efter tilmelding.
  4. Ukorrigeret svær aortastenose, svær valvulær regurgitation (undtagen mitral regurgitation på grund af venstre ventrikulær dilatation uden planlagt indgreb) eller venstre ventrikulær udstrømningsobstruktion, der kræver intervention.
  5. Aktuel atrieflimren eller atrieflimren med en gennemsnitlig ventrikulær responsrate >100 pr. minut (i hvile).
  6. Aktuel eller planlagt mekanisk kredsløbsstøtte eller hjertetransplantation.
  7. Hæmodialyse eller peritonealdialyse (aktuel eller planlagt inden for de næste 6 måneder).
  8. Dokumenteret leversygdom eller aktiv hepatitis (dvs. alanintransaminase eller aspartattransaminase >3 gange den øvre grænse for normalområdet).
  9. Aktuel eller nylig (inden for 3 år) malignitet med undtagelse af basalcellekarcinom eller pladecellekarcinom i huden eller cervikal intraepitelial neoplasi.
  10. Aktiv gastrointestinal blødning.
  11. Kvindelig deltager i den fødedygtige alder, som er gravid, ammer eller ikke er villig til at bruge tilstrækkelige præventionsforanstaltninger under undersøgelsen og i op til 5 dage efter den sidste planlagte dosis af undersøgelsesmedicin.
  12. Manglende evne til at vende tilbage til opfølgende besøg inden for de nødvendige vinduer
  13. Sideløbende i en undersøgelse med forsøgsprodukt.
  14. Ingen deltagere med aktuel COVID-19-infektion i undersøgelsen.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Ferricarboxymaltose
Ferricarboxymaltose 2 doser intravenøst ​​på 15 mg/kg til en maksimal individuel dosis på 750 mg med 7 dages mellemrum og en maksimal kombineret dosis på 1500 mg - gentaget hver 6. måned som angivet af resultaterne af jernindekser.
Medicin: Ferricarboxymaltose
Intravenøst ​​jern
Andre navne:
  • Injectafer, Ferinject
Placebo komparator: Placebo
Normalt saltvand 15 ml - 2 doser med 7 dages mellemrum gentaget hver 6. måned.
Medicin: Placebo
Normal saltvandsopløsning
Andre navne:
  • Saltopløsning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Forekomst af dødsfald
Tidsramme: 1 år
1 år
Hyppighed af indlæggelse på grund af hjertesvigt
Tidsramme: 1 år
1 år
Ændring i 6MWT afstand
Tidsramme: 6 måneder
6 måneder

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

American Regent, Inc.

Samarbejdspartnere

Duke Clinical Research Institute

Efterforskere

  • Studiestol: Adrian F Hernandez, MD, Duke Clinical Research Institute

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.

Generelle publikationer

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)

15. marts 2017

Primær færdiggørelse (Faktiske)

2. februar 2023

Studieafslutning (Faktiske)

2. februar 2023

Datoer for studieregistrering

Først indsendt

25. januar 2017

Først indsendt, der opfyldte QC-kriterier

27. januar 2017

Først opslået (Skøn)

31. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. april 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2023

Sidst verificeret

1. april 2023

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1VIT15043

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 .

Kliniske forsøg med Hjertefejl

Kliniske forsøg med Ferricarboxymaltose

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Türkiye

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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